CRF retention at the end of trial

[Development QA]

With reference to ICH E6, the Sponsor should have the (original) CRFs (8.3.14) and corrections (8.3.15) in the TMF . How are Sponsors meeting this requirement when working with Phase 1 units using early phase EDC? Often these EDC systems have non-CRF source data, CRF and data queries in the same system and difficulty providing a recognisable CRF and record of CRF changes for the Sponsor at the end of trial.

[rammellconsult]

Great question!! I too am interested in how industry is meeting this requirement. All too often, sponsors get enthusiastic about using the technology without really getting answers to some critical questions:

- How does the system generate a recognisable CRF that meets ICH E6 requirements?
- How does the system generate a CRF in real time, that can be locked down in real time and held by the investigator (per ICH E6)?
- How does the system allow the data to be exported in a user-friendly format that is acceptable during an inspection (including audit trails, for example)?
- How does the system export all the data in a format that is suitable for retention and access, whilst maintaining data integrity, for a minimum of 25 years, independent of the original EDC system software?

These questions should be asked of the EDC vendor BEFORE starting the trial.

[Development QA]

Perhaps some of the forum members working for Phase 1 CROs could offer some insight?