Veeva Clinical Basics: eTMF
General
A document should be stored in Veeva eTMF if the document:
- Is related to a Clinical Trial (all documents loaded into eTMF must be tagged with a study).
- Needs to be available for a Clinical Inspection.
Examples
- Trial Master File Plan
- Monitoring Visit Reports
- QP (Qualified Person) Certification
- Protocol Signature Page
- Informed Consent Form
Connected Vaults
If you have both Veeva eTMF and Veeva RIM, the following documents should initially be created in Submissions and will be brought into eTMF via the automated connection:
- Protocol and Protocol Amendments
- Published Reports and Published Study Reports
- Synopsis
- Investigator Brochure
Veeva RIM Basics: Submissions
General Guidelines
A document should be stored in Veeva RIM if the document:
- Is a regulatory document submitted to health authorities in eCTD/non-eCTD Submissions (e.g., IND submissions, NDA submissions) outside of clinical trials.
- Needs approval by regulatory agencies (e.g., FDA), such as drug applications, safety reports, or variations to existing approvals.
- Is a Regulatory Correspondences sent to/from a Health Authority (outside of a given submission).
Examples
- Regulatory Forms, Cover Letters and Correspondences
- Labeling Documents
- Literature References
- Nonclinical Documents
- Pharmacovigilance Periodic Reports
- Quality Drug Master Files, Quality Overall Summaries
Crosslinking
Documents that should be viewed in Veeva RIM but should be authored in QualityDocs and brought over via crosslinking are:
- Certificates of Analyses
- Methods and Validation Reports
Connected Vaults
If you have both Veeva eTMF and Veeva RIM, the following documents should be initially created in eTMF and will be brought into Veeva RIM Basics: Submissions via the automated connection.
- Annotated CRF
- Audit Certificate
- Data Management Plan
- 1572
- Informed Consent Form
- IRB or IEC Submission
- PI CV
- Protocol Deviations
- Protocol Signature Page
- Randomization Plan
- Randomization Procedure
- Randomization Programming
- Sample Case Report Form
- Standardization Methods
Veeva Quality Basics: QualityDocs
General Guidelines
A document should be stored in Veeva QualityDocs if the document:
- It is a controlled document related to Good Manufacturing Practice and overall quality management.
- Your document pertains to things like manufacturing processes, quality control procedures, or standard operating procedure (SOPs).
- You need to provide GxP training on the document.
Examples
- Standard Operating Procedures (SOPs)
- Work Instructions
- Master Batch Records
- Executed Records, such as Test Scripts
- Agreements
- Training Materials
Crosslinking
Documents that are visible within Veeva QualityDocs, but should be authored in Veeva RIM and brought over via crosslinking are:
- Labels
- CMC Documents