- Published
- Updated
- Sources checked
A revised consent form is not implemented when its PDF reaches the site. The operational question is who needs new information, when it must be discussed and which controlled version documents that discussion.
Define the affected participants
Use the applicable ethics decisions, TİTCK guidance and sponsor medical assessment to determine the required action. Do not assume every participant group has the same status: screening, treatment, follow-up and completed participation can create different information needs. Document the rationale for any differences.
Create a reconsent decision log
Our recommended log uses coded participant identifiers, current consent version, required new version, communication owner and completion status. Keep personal identifiers in the authorized site record. Link the log to the approved document and site implementation date rather than circulating uncontrolled participant lists by email.
Control site rollout
- Confirm the applicable decision and the exact version released to each site.
- Separate new screening consent from information or reconsent for existing participants.
- Withdraw obsolete blank forms from clinical work areas while preserving archived history.
- Reconcile missed visits, unavailable participants and unresolved discussions with the investigator.
Resolve missed discussions
Check a sample of records after rollout to verify the discussion, date and signatures are supported. If a participant used an outdated form, assess the actual information gap and corrective action. Replacing the page or retrospectively changing a date cannot recreate a consent discussion.
Frequently asked questions
- Does emailing the revised form complete reconsent?
- No. Track the required participant discussion and its documentation under the applicable plan.
- Should superseded signed forms be removed?
- Retain historical consent evidence; control obsolete blank copies separately.