Veeva Clinical Basics Document Types

This reference outlines the clinical document types used to standardize organization in Clinical Basics. Each table represents a primary Document Type, detailing the specific Artifact Number, Subtype, Classification, and the Autoname naming conventions used in Clinical Basics to ensure consistent and intuitive structure.

Trial Management

Artifact #	Subtype	Classification	Autoname	Description
01.01.01	Trial Oversight	Trial Master File Plan	Trial Master File Plan	To describe how records for the trial will be managed and stored during and after the trial, including study-specific processes and documentation for archiving and destruction. To include TMF filing structure to be used. May include TMF content list, filing structure and chain of custody records. Artifact can include any evidence of plan execution including, but not limited to: plan, reports, checklists, etc.
01.01.02	Trial Oversight	Trial Management Plan	Trial Management Plan	To describe overall strategy for timelines, management and conduct of the trial and typically makes reference to other artifacts. Artifact can include details on contingency plan covering details for site start up planning.
01.01.03	Trial Oversight	Quality Plan	Quality Plan	To describe the operational techniques and activities undertaken within the quality management system to verify that the requirements for quality of the trial related activities have been fulfilled.
01.01.04	Trial Oversight	List of SOPs Current During Trial	List of SOPs Current During Trial	To document which standard operating procedures (SOPs) and which versions were in effect for the duration of the trial and for filing in the TMF.
01.01.05	Trial Oversight	Operational Procedure Manual	(Product Name) - Operational Procedure Manual	To describe trial-related processes not covered by formal standard operating procedures. Includes manuals given to sites by the sponsor or 3rd Party.
01.01.06	Trial Oversight	Recruitment Plan	Recruitment Plan	To describe the planned subject enrolment/recruitment goals during the trial, including contingency plans. Artifact can include any evidence of plan execution.
01.01.07	Trial Oversight	Communication Plan	Communication Plan	To describe communication strategy and plans between trial stakeholders, including communication escalation procedures/strategy.
01.01.08	Trial Oversight	Monitoring Plan	Monitoring Plan	To describe how monitoring will be implemented during the trial, including strategy for source data verification. Artifact can include any evidence of plan execution.
01.01.09	Trial Oversight	Medical Monitoring Plan	Medical Monitoring Plan	To describe how medical surveillance of trial subjects will be assured during the trial. Artifact can include any evidence of plan execution.
01.01.10	Trial Oversight	Publication Policy	Publication Policy	To describe the policy for publishing the trial results if publication policy is not captured within the protocol.
01.01.11	Trial Oversight	Debarment Statement	Debarment Statement	To verify whether the applicant or any of its principals is currently debarred, suspended, proposed for debarment, or declared ineligible for federal programs.
01.01.12	Trial Oversight	Trial Status Report	Trial Status Report	Routine trial status progress report generated by the sponsor or 3rd Party and distributed to trial stakeholders.
01.01.13	Trial Oversight	Investigator Newsletter	Investigator Newsletter	To inform investigative staff of common implementation issues and of the progress of the trial.
01.01.14	Trial Oversight	Audit Certificate	Audit Certificate	Documentation to confirm that an audit was performed (does not contain the audit report).
01.01.15	Trial Oversight	Filenote Master List	Filenote Master List	To provide a consolidated list/index of file notes generated during the trial.
01.01.16	Trial Oversight	Risk Management Plan	Risk Management Plan	To describe the potential hazards associated with the trial, including an assessment of the likelihood of those hazards occurring and the impact of those hazards on the conduct and results of the trial.
01.01.17	Trial Oversight	Vendor Management Plan	Vendor Management Plan	To describe the overall management strategy for vendors used to conduct trial-related activities. May include assignment of responsibilities and oversight activities.
01.01.18	Trial Oversight	Roles and Responsibility Matrix	Roles and Responsibility Matrix	To identify range and distribution of tasks and responsibilities; may define internal assignment and all external parties involved in the conduct of the trial.
01.01.19	Trial Oversight	Transfer of Regulatory Obligations	Transfer of Regulatory Obligations	To specify the transfer of regulatory obligations from sponsor to each Affiliate/CRO/Vendor and may include other agreements related to the conduct of the trial.
01.01.20	Trial Oversight	Operational Oversight	Operational Oversight	Documentation to show evidence of sponsor oversight of study, as well as any key decisions taken and the supporting rationale.
01.02.01	Trial Team	Trial Team Details	Trial Team Details	To define trial roles, contact details and structure of the trial team - both sponsor and third parties; optionally this may include an organizational chart.
01.02.02	Trial Team	Trial Team Curriculum Vitae	(Personnel Name) - Trial Team Curriculum Vitae	To document qualifications and eligibility of sponsor trial team members. Documentation for third party trial team members may be filed here if not in Zone 9.
01.03.01	Trial Committee	Committee Process	Committee Process	To describe the purpose and mode of operation/manner of working of the Independent Trial Committee, which may be established to provide independent oversight of a trial.
01.03.02	Trial Committee	Committee Member List	Committee Member List	To document the current composition of a Trial Committee. Can be part of the Charter.
01.03.03	Trial Committee	Committee Output	Committee Output	To document any agreements or significant decisions regarding trial conduct, protocol violations, adverse event reporting, or unblinding.
01.03.04	Trial Committee	Committee Member Curriculum Vitae	(Personnel Name) - Committee Member Curriculum Vitae	To document qualifications and eligibility of the Committee Member to provide assessments, at set intervals, the progress of a clinical trial.
01.03.05	Trial Committee	Committee Member Financial Disclosure Form	Committee Member Financial Disclosure Form	To certify that no financial arrangements with a Committee Member have been made where study outcome could affect compensation.
01.03.06	Trial Committee	Committee Member Contract	Committee Member Contract	To document agreement of trial requirements between sponsor or 3rd Party and Committee Member.
01.03.07	Trial Committee	Committee Member Confidentiality Disclosure Agreement	Committee Member Confidentiality Disclosure Agreement	A document between the sponsor and the Committee Member that defines the terms and basic criteria to assure that the parties will not disclose confidential information.
01.04.01	Meetings	Kick-off Meeting Material	Kick-off Meeting Material	Agenda, presentation materials and other documentation made available for attendees of the trial kick-off meeting, including follow-up correspondence.
01.04.02	Meetings	Trial Team Training Material	Trial Team Training Material	Trial-relevant training materials, including use of specialized systems.
01.04.03	Meetings	Investigators Meeting Material	Investigators Meeting Material	Agenda, presentation materials and other documentation made available for attendees of the investigator meeting(s). Includes follow-up correspondence.
01.04.04	Meetings	Trial Team Evidence of Training	Trial Team Evidence of Training	To document completion of trial team training, including certification or evidence of training (attendance sheets). Includes training for any specialized systems.
01.05.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
01.05.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
01.05.03	General	Other Meeting Material	Other Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during any other internal or external zone-related meeting which is not specifically listed in this Reference Model.
01.05.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone. Filenotes referencing general topics and/or more than one zone should be filed in Zone 1.

Central Trial Documents

Artifact #	Subtype	Classification	Autoname	Description
02.01.01	Product and Trial Documentation	Investigator’s Brochure	(Product Name) - Investigator’s Brochure	To provide relevant and current clinical and non-clinical data on the investigational product(s) that is related to the study of the product in human subjects.
02.01.02	Product and Trial Documentation	Protocol	Protocol	To describe the objective(s), design, methodology, statistical considerations and organization of a trial. Usually also contains the background and rationale for the trial.
02.01.03	Product and Trial Documentation	Protocol Synopsis	Protocol Synopsis	A summary of the pertinent points of the protocol. A local language version may be translated from core (English) or provided in local language only.
02.01.04	Product and Trial Documentation	Protocol Clarification Letter	Protocol Clarification Letter	Clarification of a protocol. May include a non-substantial amendment, such as administrative changes. Also known as: Letter of Amendment (LoA), Protocol Letter of Amendment. Used to communicate minor or administrative changes to the protocol.
02.01.04	Product and Trial Documentation	Protocol Summary of Changes	Protocol Summary of Changes	To describe description of change(s) to or formal clarification of a protocol. Includes justification for a non-substantial amendment, such as administrative changes.
02.01.05	Product and Trial Documentation	Financial Disclosure Summary	Financial Disclosure Summary	Summary documentation of compliance with financial disclosure reporting requirements, per company and/or local government regulation.
02.01.06	Product and Trial Documentation	Insurance	Insurance	To document that compensation to subject(s) for trial-related injury will be available. May include policy and certificate of insurance.
02.01.07	Product and Trial Documentation	Sample Case Report Form	Sample Case Report Form	Blank forms/templates in paper form or e-Format to capture the data points of the protocol.
02.01.10	Product and Trial Documentation	Report of Prior Investigations	Report of Prior Investigations	To include reports of all prior clinical, animal and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.
02.01.11	Product and Trial Documentation	Marketed Product Material	Marketed Product Material	Materials available in the legal pharmacologic description of a drug or device, subject to detailed regulatory specifications.
02.02.01	Subject Documentation	Subject Diary	Subject Diary	To document subject data captured by the subject and external to the CRF (blank forms/templates).
02.02.02	Subject Documentation	Subject Questionnaire	Subject Questionnaire	To capture specific subject related information through a series of questions (blank forms/templates).
02.02.03	Subject Documentation	Informed Consent Form	Informed Consent Form	To document that the appropriate written information (content and wording) has been given to subjects regarding the trial.
02.02.04	Subject Documentation	Subject Information Sheet	Subject Information Sheet	To document information provided to subjects to support their decision about whether or not to participate in the trial.
02.02.05	Subject Documentation	Subject Participation Card	Subject Participation Card	To be provided to the subject to carry to document trial participation (blank template).
02.02.06	Subject Documentation	Advertisements for Subject Recruitment	Advertisements for Subject Recruitment	Materials used in clinical trial recruitment campaigns; approved by the IRB/IEC to ensure recruitment measures are appropriate.
02.02.07	Subject Documentation	Other Information Given to Subjects	Other Information Given to Subjects	Materials provided to the subject to further assist with understanding the trial requirements or concepts.
02.03.01	Reports	Clinical Study Report	Clinical Study Report	To describe final or interim results and interpretation of trial of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
02.03.02	Reports	Bioanalytical Report	Bioanalytical Report	To present and summarize the relevant top line findings of the bioanalytical aspects of the interim or final analysis.
02.04.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
02.04.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
02.04.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
02.04.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Regulatory

Artifact #	Subtype	Classification	Autoname	Description
03.01.01	Trial Approval	Regulatory Submission	Regulatory Submission	A set of documents, along with required associated regulatory forms and correspondence, submitted to one or more regulatory authorities.
03.01.02	Trial Approval	Regulatory Approval Notification	Regulatory Approval Notification	A documented notification received from a regulatory authority stating that the Submission has been received and approved.
03.01.03	Trial Approval	Notification of Regulatory Identification Number	Notification of Regulatory Identification Number	Document identifying unique identification number used to uniquely identify the trial or the trial level in that regulatory system.
03.01.04	Trial Approval	Public Registration	Public Registration	Documentation related to registration of clinical trials in public registries such as ClinicalTrials.gov.
03.02.01	Investigational Medicinal Product	Import or Export License Application	Import or Export License Application	An application made to one or more regulatory agencies requesting a license to import or export the investigational product.
03.02.02	Investigational Medicinal Product	Import or Export License	Import or Export License	A document issued by a national government authorizing the importation or exportation of certain goods into its territory.
03.03.01	Trial Status Reporting	Notification to Regulatory Authority of Safety or Trial Information	Notification to Regulatory Authority of Safety or Trial Information	Notification to Regulatory Authorities of any trial events that could alter the regulatory authority’s approval/favorable opinion of the trial.
03.03.02	Trial Status Reporting	Regulatory Progress Report	Regulatory Progress Report	Reports concerning trial conduct, progress and status that are required to be periodically submitted to relevant regulatory authorities.
03.03.03	Trial Status Reporting	Regulatory Notification of Trial Termination	Regulatory Notification of Trial Termination	Document detailing the termination of a trial, whether upon completion or premature termination.
03.04.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
03.04.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
03.04.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
03.04.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

IRB or IEC and other Approvals

Artifact #	Subtype	Classification	Autoname	Description
04.01.01	IRB or IEC Trial Approval	IRB or IEC Submission	IRB or IEC Submission	Documents describing the trial or changes/updates to the trial submitted to an IRB/IEC for approval, including recruitment materials.
04.01.02	IRB or IEC Trial Approval	IRB or IEC Approval	IRB or IEC Approval	Documentation received from IRB/IEC in response to submission indicating approval/acknowledgement of trial and any specific conditions.
04.01.03	IRB or IEC Trial Approval	IRB or IEC Composition	IRB or IEC Composition	Documentation that the IRB/IEC consists of a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science and ethics of the trial.
04.01.04	IRB or IEC Trial Approval	IRB or IEC Documentation of Non-Voting Status	IRB or IEC Documentation of Non-Voting Status	Documentation verifying non-voting members of the IRB/IEC if the investigator or sub-investigator is on the IRB/IEC.
04.01.05	IRB or IEC Trial Approval	IRB or IEC Compliance Documentation	IRB or IEC Compliance Documentation	Documentation that the IRB/IEC is performing its function according to written operating procedures and is in compliance with regulations.
04.02.01	Other Committees	Other Submissions	Other Submissions	A set of documents describing the trial or changes/updates to the trial submitted to a committee other than the IRB/IEC for approval.
04.02.02	Other Committees	Other Approvals	Other Approvals	Approval documentation received from a committee other than the IRB/IEC in response to submission.
04.03.01	Trial Status Reporting	Notification to IRB or IEC of Safety Information	Notification to IRB or IEC of Safety Information	To assure the IRB/IEC are promptly notified of all findings (new, important information on serious adverse events and other relevant safety information).
04.03.02	Trial Status Reporting	IRB or IEC Progress Report	IRB or IEC Progress Report	Regular reports concerning trial conduct, other than safety reports, issued to the IRB/IEC by the sponsor/3rd Party and/or investigator.
04.03.03	Trial Status Reporting	IRB or IEC Notification of Trial Termination	IRB or IEC Notification of Trial Termination	Document detailing the termination of a trial, whether upon completion or premature termination.
04.04.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
04.04.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
04.04.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
04.04.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Site Management

Artifact #	Subtype	Classification	Autoname	Description
05.01.01	Site Selection	Site Contact Details	Site Contact Details	To document contact information for primary points of contact at the site (e.g. Principal Investigator, Institution Name and Address, and other key site staff).
05.01.02	Site Selection	Confidentiality Agreement	(Personnel Name) - Confidentiality Agreement	A document between the sponsor and an outside party (Investigator or Institution) that defines the terms and basic criteria to assure that the parties will not disclose confidential information.
05.01.03	Site Selection	Feasibility Documentation	Feasibility Documentation	To document site feasibility for the given protocol.
05.01.04	Site Selection	Pre-Study Visit Confirmation Letter	Pre-Study Visit Confirmation Letter	To document onsite visit to determine qualification of site to participate in the trial.
05.01.04	Site Selection	Pre-Study Visit Report	Pre-Study Visit Report	To document onsite visit to determine qualification of site to participate in the trial.
05.01.05	Site Selection	Sites Evaluated but not Selected	Sites Evaluated but not Selected	Documentation related to sites evaluated but not selected for the trial.
05.02.01	Site Set-up	Acceptance of Investigator Brochure	Acceptance of Investigator Brochure	To document that relevant and current scientific information about the investigational product has been provided to the investigator.
05.02.02	Site Set-up	Protocol Signature Page	Protocol Signature Page	To document investigator and sponsor agreement to the protocol.
05.02.04	Site Set-up	Principal Investigator Curriculum Vitae	(Personnel Name) - Principal Investigator Curriculum Vitae	To document qualifications and eligibility of the Principal Investigator to conduct trial and/or provide medical supervision.
05.02.05	Site Set-up	Subinvestigator Curriculum Vitae	(Personnel Name) - Subinvestigator Curriculum Vitae	To document qualifications and eligibility of any sub-Investigators to conduct trial and/or provide medical supervision at the site.
05.02.06	Site Set-up	Other Curriculum Vitae	(Personnel Name) - Other Curriculum Vitae	To document qualifications and eligibility of site personnel other than the Principal Investigator or Sub-Investigators.
05.02.07	Site Set-up	Site Staff Qualification Supporting Information	(Personnel Name) - Site Staff Qualification Supporting Information	To document site staff qualifications not previously outlined on CVs. May include list of studies, publications, training records, etc.
05.02.08	Site Set-up	Form FDA 1572	(Personnel Name) - Form FDA 1572	For IND trial, 1572 must be completed globally for FDA submission.
05.02.09	Site Set-up	Investigator Regulatory Agreement	(Personnel Name) - Investigator Regulatory Agreement	A regulatory statement from the investigator required by certain health authorities.
05.02.10	Site Set-up	Financial Disclosure Form	(Personnel Name) - Financial Disclosure Form	To document financial disclosures, certification documentation and conflicts of interest.
05.02.11	Site Set-up	Data Privacy Agreement	(Personnel Name) - Data Privacy Agreement	To document agreement between sponsor and Site Staff regarding national or regional data privacy requirements.
05.02.12	Site Set-up	Clinical Trial Agreement	Clinical Trial Agreement	To document agreement of trial requirements between sponsor or 3rd Party and site/PI. Includes indemnity unless separately documented.
05.02.13	Site Set-up	Indemnity	Indemnity	To provide legal protection in the event of an unforeseen adverse circumstance arising from participation in the trial.
05.02.14	Site Set-up	Other Financial Agreement	Other Financial Agreement	To document agreement of trial requirements between other parties involved in the conduct of the trial.
05.02.17	Site Set-up	IP Site Release Documentation	IP Site Release Documentation	To document approval for sites to receive drug supply / investigational product.
05.02.18	Site Set-up	Site Signature Sheet	Site Signature Sheet	To document delegation by the Principal Investigator of trial specific tasks to site personnel conducting the trial.
05.02.19	Site Set-up	Investigators Agreement (Device)	Investigators Agreement (Device)	Non-financial agreement between the sponsor and the investigator documenting the various responsibilities as outlined in the applicable regulations.
05.02.20	Site Set-up	Coordinating Investigator Documentation	(Personnel Name) - Coordinating Investigator Documentation	Documentation to show the approval of a coordinating investigator for a specific region or group of investigators.
05.03.01	Site Initiation	Site Initiation Visit Confirmation Letter	SIV Confirmation Letter	To document that trial procedures were reviewed with the investigator and the trial personnel and confirm the site meets requirements to begin trial procedures.
05.03.01	Site Initiation	Site Initiation Visit Report	Site Initiation Visit Report	To document that trial procedures were reviewed with the investigator and the trial personnel and confirm the site meets requirements to begin trial procedures.
05.03.02	Site Initiation	Site Training Material	Site Training Material	Training materials used to train the sites. Materials may be related to Electronic Data Capture (EDC), Interactive Response Technology (IRT), or other trial-specific systems.
05.03.03	Site Initiation	Site Evidence of Training	Site Evidence of Training	To document completion of site training by relevant site personnel. Documentation includes attendance and certification records.
05.04.01	Site Management	Subject Log	Subject Log	To anonymously list all subjects including screened, screen failures and enrolled for the sponsor.
05.04.02	Site Management	Source Data Verification	Source Data Verification	To document source data and associated verification activity.
05.04.03	Site Management	Monitoring Visit Confirmation Letter	IMV Confirmation Letter	To document site visits monitoring trial conduct and compliance of the site, may include confirmation letters/emails.
05.04.03	Site Management	Monitoring Visit Report	Monitoring Visit Report - (Actual End Date)	To document site visits monitoring trial conduct and compliance of the site, may include confirmation letters/emails.
05.04.04	Site Management	Visit Log	Visit Log	To document monitoring visit dates and attendees.
05.04.05	Site Management	Additional Monitoring Activity	Additional Monitoring Activity	To document additional monitoring activity such as co-visits and sponsor-specific monitoring activities.
05.04.06	Site Management	Protocol Deviations	Protocol Deviations	To document non-compliance/deviations to the protocol.
05.04.07	Site Management	Financial Documentation	Financial Documentation	Includes all invoices, receipts, payment summaries relating to the trial.
05.04.08	Site Management	Close-Out Visit Confirmation Letter	Close-Out Visit Confirmation Letter	To document trial activities are completed for site closure prior to trial completion, may include confirmation letters/emails.
05.04.08	Site Management	Close-Out Visit Report	Close-Out Visit Report	To document trial activities are completed for site closure prior to trial completion, may include confirmation letters/emails.
05.04.09	Site Management	Notification to Investigators of Safety Information	Notification to Investigators of Safety Information	To assure investigators are promptly notified of all findings (new, important information on serious adverse events and other relevant safety information).
05.04.12	Site Selection	Pre-Study Visit Follow Up Letter	Pre-Study Visit Follow Up Letter	To document site visit follow-up.
05.04.12	Site Initiation	Site Initiation Visit Follow Up Letter	SIV Follow Up Letter	To document site visit follow-up.
05.04.12	Site Management	Close-Out Visit Follow Up Letter	Close-Out Visit Follow Up Letter	To document site visit follow-up.
05.04.12	Site Management	Monitoring Visit Follow Up Letter	IMV Follow Up Letter	To document site visit follow-up.
05.04.13	Site Management	Subject Eligibility Verification Forms and Worksheets	Subject Eligibility Verification Forms and Worksheets	Eligibility forms for qualification of trial subjects, may include inclusion/exclusion criteria, lab reports, doctor notes, etc.
05.05.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
05.05.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
05.05.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
05.05.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

IP and Trial Supplies

Artifact #	Subtype	Classification	Autoname	Description
06.01.01	IP Documentation	IP Supply Plan	IP Supply Plan	To describe the details of IP supply including quantity, packaging, active and placebo components, and distribution planning.
06.01.02	IP Documentation	IP Instructions for Handling	IP Instructions for Handling	To instruct on how the IP should be handled during transit and stored upon arrival at the distribution center, depot and/or site.
06.01.03	IP Documentation	IP Sample Label	IP Sample Label	A sample of each IP label type (for every pack and every language) to be used in the trial; approval status must be clearly documented.
06.01.04	IP Documentation	IP Shipment Documentation	IP Shipment Documentation	To record details of the shipment process including approval, requests, dispatch, tracking and receipts.
06.01.05	IP Documentation	IP Accountability Documentation	IP Accountability Documentation	To document records of the allocation of IP to/from a distribution center, depot, trial site and/or site to subject and return of unused supplies.
06.01.06	IP Documentation	IP Transfer Documentation	IP Transfer Documentation	To document the transfer of IP between depots and sites (within or across protocols).
06.01.07	IP Documentation	IP Re-labeling Documentation	IP Re-labeling Documentation	To document the plan for the re-labeling process and confirmation of re-labeling completion.
06.01.08	IP Documentation	IP Recall Documentation	IP Recall Documentation	To document the plan for the recall process for the IP and confirmation of recall completion.
06.01.09	IP Documentation	IP Quality Complaint Form	IP Quality Complaint Form	To document or record an IP quality complaint.
06.01.10	IP Documentation	IP Return Documentation	IP Return Documentation	To record details of IP returns to/from a distribution center, depot and/or trial site.
06.01.11	IP Documentation	IP Certificate of Destruction	IP Certificate of Destruction	To document the confirmation of destruction of IP at the end of a trial.
06.01.12	IP Documentation	IP Retest and Expiry Documentation	IP Retest and Expiry Documentation	To document the batch retesting/analyses of IP for stability confirmation and expiry extensions.
06.02.01	IP Release Process Documentation	QP (Qualified Person) Certification	QP (Qualified Person) Certification	To confirm that any IP from another country has been manufactured and checked in accordance with standards of Good Manufacturing Practice (GMP).
06.02.02	IP Release Process Documentation	IP Regulatory Release Documentation	IP Regulatory Release Documentation	To document the regulatory IP release process.
06.02.03	IP Release Process Documentation	IP Verification Statements	IP Verification Statements	Any certificate, license or other documentation required by a specific regulation to verify the quality, source, or composition of IP.
06.02.04	IP Release Process Documentation	Certificate of Analysis	Certificate of Analysis	To document identity, purity and strength of the IP(s) to be used in the trial, in accordance with the specifications of the IP.
06.03.01	IP Allocation Documentation	IP Treatment Allocation Documentation	IP Treatment Allocation Documentation	To document the treatment allocation or device serial numbers for each subject; used if urgent unblinding or code break is needed.
06.03.02	IP Allocation Documentation	IP Unblinding Plan	IP Unblinding Plan	To describe the plan and procedures to be taken should the action of breaking the blind for an individual subject be urgently needed.
06.03.03	IP Allocation Documentation	IP Treatment Decoding Documentation	IP Treatment Decoding Documentation	To document the action of breaking the blind for an individual subject, urgently if needed, or when interim or final unblinding occurs.
06.04.01	Storage	IP Storage Condition Documentation	IP Storage Condition Documentation	To document the unique storage conditions of the IP at the sponsor, distribution center, depot and/or trial site.
06.04.02	Storage	IP Storage Condition Excursion Documentation	IP Storage Condition Excursion Documentation	To record excursions for IP from the acceptable pre-defined condition range either during transit or storage.
06.04.03	Storage	Maintenance Logs (Device)	Maintenance Logs (Device)	To record activities and times when quality of condition of IP, Non-IP and other trial supplies is assessed over periods of time.
06.05.01	Non-IP Documentation	Non-IP Supply Plan	Non-IP Supply Plan	To describe the details and quantity of non-IP supplies needed to fulfill the trial protocol requirements over the life of the trial.
06.05.02	Non-IP Documentation	Non-IP Shipment Documentation	Non-IP Shipment Documentation	To record details of the shipment of non-IP supplies needed to fulfill the trial protocol requirements.
06.05.03	Non-IP Documentation	Non-IP Return Documentation	Non-IP Return Documentation	To inventory the returns of certain non-IP supplies needed to fulfill the trial protocol requirements.
06.06.01	Interactive Response Technology	IRT User Requirement Specification	IRT User Requirement Specification	To document end user requirements from design and capabilities of an interactive response technology (IRT) such as Interactive Voice/Web Response System (IVRS/IWRS).
06.06.02	Interactive Response Technology	IRT Validation Certification	IRT Validation Certification	To confirm the validation status of the interactive response technology (IRT).
06.06.03	Interactive Response Technology	IRT User Acceptance Testing (UAT) Certification	IRT User Acceptance Testing (UAT) Certification	To document the acceptability of the series of assessments of the IRT performed by key users of the system.
06.06.04	Interactive Response Technology	IRT User Manual	IRT User Manual	To provide instructions and define the operational instructions for the IRT for the user.
06.06.05	Interactive Response Technology	IRT User Account Management	IRT User Account Management	To capture account management details for all users who received access to the IRT system; should include security role, date of access granted and removed.
06.07.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
06.07.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
06.07.03	General	Meeting Material	Meeting Material (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
06.07.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Safety Reporting

Artifact #	Subtype	Classification	Autoname	Description
07.01.01	Safety Documentation	Safety Management Plan	Safety Management Plan	To describe the end-to-end process for the ongoing safety evaluation for the investigational product.
07.01.02	Safety Documentation	Pharmacovigilance Database Line Listing	Pharmacovigilance Database Line Listing	Listing of trial data for a single trial used for a variety of safety evaluation of the investigational product purposes.
07.02.01	Trial Status Reporting	Expedited Safety Report	Expedited Safety Report	To document unexpected serious adverse drug reactions and other safety information; submitted to regulatory authorities and investigators as required.
07.02.02	Trial Status Reporting	SAE Report	SAE Report	To organize critical data around a serious adverse event, adverse event and/or a laboratory abnormality as identified in the protocol.
07.02.03	Trial Status Reporting	Pregnancy Report	Pregnancy Report	To organize critical data around a pregnancy that occurred whilst either the male or the female subject was participating in the trial.
07.02.04	Trial Status Reporting	Special Events of Interest	Special Events of Interest	To organize critical data around a special event of interest, one that is of scientific and medical concern specific to the product.
07.03.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific, trial specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
07.03.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific, trial specific documents developed for the purpose of tracking activities during the course of the trial.
07.03.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
07.03.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Central and Local Testing

Artifact #	Subtype	Classification	Autoname	Description
08.01.01	Facility Documentation	Certification or Accreditation	Certification or Accreditation	To document recognition and approval by an authorized accrediting body that the central or local laboratory meets acceptable standards.
08.01.02	Facility Documentation	Laboratory Validation Documentation	Laboratory Validation Documentation	To document through use of control data that a central or local laboratory can consistently and reproducibly report results within acceptable limits.
08.01.03	Facility Documentation	Laboratory Results Documentation	Laboratory Results Documentation	Summary listings or individual subject reports provided by the central or local laboratory or other testing facility.
08.01.04	Facility Documentation	Normal Ranges	Normal Ranges	To define acceptable limits for comparative reference data from the central or local laboratory.
08.01.05	Facility Documentation	Manual	Manual	To outline the procedures to be followed in the collection, handling and shipping of samples.
08.01.06	Facility Documentation	Supply Import Documentation	Supply Import Documentation	To provide the necessary documentation required per country to allow for importation of supplies (non-drug/IP).
08.01.07	Facility Documentation	Head of Facility Curriculum Vitae	(Personnel Name) - Head of Facility Curriculum Vitae	To verify that the Head of Facility is suitably qualified to lead and oversee the management and reporting of results.
08.01.08	Facility Documentation	Standardization Methods	Standardization Methods	To confirm that two or more central or local facilities can perform the same test/procedure and obtain consistent results.
08.02.01	Sample Documentation	Specimen Label	Specimen Label	To capture critical information about the collection of a sample; may include subject ID, date and time of collection, sample type, etc.
08.02.02	Sample Documentation	Shipment Records	Shipment Records	To provide relevant details for samples sent in any one shipment.
08.02.03	Sample Documentation	Sample Storage Condition Log	Sample Storage Condition Log	To monitor and track sample storage under the appropriate conditions.
08.02.04	Sample Documentation	Sample Import or Export Documentation	Sample Import or Export Documentation	To provide the necessary documentation required per country to allow for importation/exportation of samples.
08.02.05	Sample Documentation	Record of Retained Samples	Record of Retained Samples	To document location and identification of body fluid or tissue samples being held for possible future (re)testing.
08.03.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
08.03.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
08.03.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
08.03.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Third Parties

Artifact #	Subtype	Classification	Autoname	Description
09.01.01	Third Party Oversight	Qualification and Compliance	Qualification and Compliance	To confirm that a third party meets all relevant criteria to fulfill a contractual obligation; may include a quality questionnaire, audit report, or certification.
09.01.02	Third Party Oversight	Third Party Curriculum Vitae	(Personnel Name) - Third Party Curriculum Vitae	To document qualifications and eligibility of Individual Third Party Trial Team Members.
09.01.03	Third Party Oversight	Ongoing Third Party Oversight	Ongoing Third Party Oversight	To confirm throughout the duration of a study that a third party continues to meet all relevant criteria to fulfill a contractual obligation.
09.02.01	Third Party Set-up	Confidentiality Agreement	Confidentiality Agreement	To confirm by written legal agreement that key information between parties will be prevented from being inappropriately disclosed.
09.02.02	Third Party Set-up	Vendor Selection	Vendor Selection	To identify how a third party was selected. May include details of other third parties short-listed, master vendor list details, etc.
09.02.03	Third Party Set-up	Contractual Agreement	Contractual Agreement	To document by a written dated signed agreement between two or more parties any arrangements on delegation of tasks and/or financial arrangements.
09.03.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
09.03.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
09.03.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
09.03.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Data Management

Artifact #	Subtype	Classification	Autoname	Description
10.01.01	Data Management Oversight	Data Management Plan	Data Management Plan	To identify the overall strategy for data management process for the study.
10.02.01	Data Capture	CRF Completion Requirements	CRF Completion Requirements	To provide detailed instructions on how data points on each CRF are to be completed.
10.02.02	Data Capture	Annotated CRF	Annotated CRF	To assign variable names and attributes to the fields on the CRF and to link the variables to the tables within the database.
10.02.04	Data Capture	Documentation of Corrections to Entered Data	Documentation of Corrections to Entered Data	Any documentation used to query database discrepancies and to record approved corrections to the clinical trial database.
10.02.05	Data Capture	Final Subject Data	Final Subject Data	Final subject data (EDC/ePRO/Paper) for the protocol and a copy of each site’s data by-subject.
10.03.01	Database	Database Specifications	Database Specifications	To provide a detailed framework for the database to be built for CRF data capture system.
10.03.02	Database	Edit Check Plan	Edit Check Plan	Specifications which will detect data that is illogical, unexpected, missing, redundant, or is outside of defined study parameters.
10.03.03	Database	Edit Check Programming	Edit Check Programming	The computer code which satisfies the edit check plan/specification details.
10.03.04	Database	Edit Check Testing	Edit Check Testing	To provide evidence that the data edit checks have been implemented correctly.
10.03.05	Database	Approval for Database Activation	Approval for Database Activation	Documentation that all database specification requirements have been satisfied and system can go live.
10.03.06	Database	External Data Transfer Specifications	External Data Transfer Specifications	To document import and export data specifications; includes but is not limited to diary, lab, IVRS, imaging.
10.03.07	Database	Data Entry Guidelines (Paper)	Data Entry Guidelines (Paper)	To provide detailed instructions on how CRF data is to be entered into a database; specific to a paper CRF trial.
10.03.08	Database	SAE Reconciliation	SAE Reconciliation	To document reconciliation and resolution of discrepancies between the SAEs in the safety and the clinical databases.
10.03.09	Database	Dictionary Coding	Dictionary Coding	To document the tools used in medical coding and the final coded terms; includes medical sign off of coding.
10.03.10	Database	Data QC or QA Plan and Results	Data QC or QA Plan and Results	To describe the procedures for creating and implementing a Quality Control (QC) Plan or Data Review Plan to ensure data quality.
10.03.11	Database	Database Lock and Unlock Approval	Database Lock and Unlock Approval	Confirmation that all of the requirements for database release have been met; may include all unlock and re-lock documentation.
10.03.12	Database	Database Change Control	Database Change Control	Summary of requested change, reason for change, relevant approvals, impact/risk analysis, and associated requirements and specifications.
10.04.01	EDC Management	System Account Management	System Account Management	To capture account management details for all users who received access to the system (e.g. ePRO, eCRF).
10.04.02	EDC Management	Technical Design Document	Technical Design Document	Document containing the design elements of the EDC including the variables to be collected, the data types, and any edit checks.
10.04.03	EDC Management	Validation Documents	Validation Documents	Documents establishing the project context and documentation requirements for EDC (e.g. eCRF or ePRO).
10.05.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
10.05.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
10.05.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
10.05.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.

Statistics

Artifact #	Subtype	Classification	Autoname	Description
11.01.01	Statistics Oversight	Statistical Analysis Plan	Statistical Analysis Plan	To describe the statistical aspects of the trial design, the process of data selection for all analyses, the data items to be included in or excluded from the analysis.
11.01.02	Statistics Oversight	Sample Size Calculation	Sample Size Calculation	To document the technique, assumptions and output used to calculate the sample size; can include QC and sign off.
11.02.01	Randomization	Randomization Plan	Randomization Plan	To describe the randomization scheme (e.g. number and name of treatments, strata, block size) and how the randomization will be implemented.
11.02.02	Randomization	Randomization Procedure	Randomization Procedure	To define the actual steps for how subjects are randomized in a trial.
11.02.03	Randomization	Master Randomization List	Master Randomization List	The single source on the assignment of subjects to protocol specified groups.
11.02.04	Randomization	Randomization Programming	Randomization Programming	Computer code to generate randomization number for treatment assignment.
11.02.05	Randomization	Randomization Sign Off	Randomization Sign Off	To verify that the randomization program generates the randomization number and treatment assignment correctly.
11.02.06	Randomization	End of Trial or Interim Unblinding	End of Trial or Interim Unblinding	To document and authorize the release of the randomization code and allow the trial data to be unblinded.
11.03.01	Analysis	Data Definitions for Analysis Datasets	Data Definitions for Analysis Datasets	To define the programming logic required to transform the raw dataset to the analysis dataset.
11.03.02	Analysis	Analysis QC Documentation	Analysis QC Documentation	To confirm the QC procedures planned for the analysis programs as well as the actual output of the QC steps.
11.03.03	Analysis	Interim Analysis Raw Datasets	Interim Analysis Raw Datasets	The export of raw data for interim analysis purposes. This may include CDISC datasets such as Operational Data Model (ODM).
11.03.04	Analysis	Interim Analysis Programs	Interim Analysis Programs	The suite of programs designed to generate the interim analysis outputs as referenced in the SAP.
11.03.05	Analysis	Interim Analysis Datasets	Interim Analysis Datasets	The datasets used for the interim analyses.
11.03.06	Analysis	Interim Analysis Output	Interim Analysis Output	The Tables, Listings and Figures produced from the interim analysis datasets; includes Statistics approval.
11.03.07	Analysis	Final Analysis Raw Datasets	Final Analysis Raw Datasets	The export of raw data for final analysis purposes. This may include CDISC datasets such as Operational Data Model (ODM).
11.03.08	Analysis	Final Analysis Programs	Final Analysis Programs	The suite of programs designed to generate the final analysis outputs as referenced in the SAP.
11.03.09	Analysis	Final Analysis Datasets	Final Analysis Datasets	The datasets used for the final analysis.
11.03.10	Analysis	Final Analysis Output	Final Analysis Output	The Tables, Listings and Figures produced from the final analysis datasets; includes Statistics approval.
11.03.11	Analysis	Subject Evaluability Criteria and Subject Classification	Subject Evaluability Criteria and Subject Classification	To document the decisions which define the criteria applied to evaluate each subject in the trial.
11.04.01	Report	Interim Statistical Report(s)	Interim Statistical Report(s)	To summarize the relevant statistical aspects of the interim analysis. May be appended to the CSR.
11.04.02	Report	Statistical Report	Statistical Report	To summarize the relevant statistical aspects of the final analysis. May be appended to the CSR.
11.05.01	General	Relevant Communications	Relevant Communications - (Document Date)	Zone-specific agreements, significant discussions or relevant information, but not specifically listed in this Reference Model.
11.05.02	General	Tracking Information	Tracking Information - (Document Date)	Zone-specific documents developed for the purpose of tracking activities during the course of the trial.
11.05.03	General	Meeting Material	Meeting Material - (Document Date)	Agenda, presentation materials and other documentation generated during an internal or external zone-related meeting.
11.05.04	General	Filenote	Filenote - (Document Date)	To document any decision or to clarify any information relating to this zone.