What is it? Why is it important?
In a study strict document management requirements exist.
All information collected and applied in a study must be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
GCP chapter 8 and ISO Annex E provide an overview of documents to be collected prior-, during-, and upon study completion.
- Essential documents play a key role in successful study management, and provide written evidence that the study was conducted in compliance with GCP
- Upon study termination essential documents must be archived during a pre-determined number of years.
- The study can be audited or inspected at any time by the EC or RA.
What do I need to do?
Implement a document filing system based on the following filing systems:
- The TMF: Files documents and activities performed by the SP-INV and the trial site(s).
- The ISF: Files documents and activities performed at a particular study site. Information on participant identification is exclusively filed in the ISF and remains at the site.
Document filing should at any time be accurate and current.
For more information refer to Documents in this Study Guide.
Extent of documents collected and filed depends on:
- Study type (e.g. clinical (ClinO), non-clinical (HRO))
- Risk category (e.g. category A, B or C). A higher risk category usually requires more extensive documentation
- Mono- versus multicentre studies
- Study complexity (e.g. study design, numbers of participants included, study duration)
A successful document management system, whether electronic or paper-based, requires ongoing oversight and maintenance.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guidelines
- 8. Essential documents for the conduct of a clinical trial
- 4.9.4 Retention of study documents
- 4.9.5 Document archiving
- 5.5.6-7-8 Archiving of SP-INV documents
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- Annex E Essential clinical investigational documents
- 7.5 Clinical investigational documents and documentation
- 7.8 Document and data control
- 8.6 Document retention