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- Published
- Updated
- Sources checked
A new investigator brochure can change how a study understands risk even when the protocol remains unchanged. File replacement alone does not show that sites have assessed the information or acted on it.
Read the change summary critically
Check TİTCK application and safety guidance for the applicable document update and reporting context. Compare the revised brochure with its predecessor, especially new risks and reference safety information. Do not treat the sponsor's publication date as automatic evidence that every local implementation condition has been satisfied.
Build a cross-document impact record
We recommend an impact record linking each material change to the protocol, consent, pharmacy materials, investigator training and safety systems. Assign medical review to the appropriate function. If no downstream change is proposed, document why the new information does not require it rather than leaving the field blank.
Check site implementation
- Reconcile brochure version, date, change summary and referenced safety information.
- Assess implications for ongoing participants and the consent information they have received.
- Record applicable submissions or notifications and the relevant decision evidence.
- Confirm site acknowledgement, targeted training and controlled withdrawal of obsolete copies.
Preserve the safety reasoning
Archive the assessment with both brochure versions so later safety decisions can be reconstructed. When the brochure and protocol describe risks differently, obtain a documented resolution. Avoid asking a coordinator to reconcile a medical inconsistency through informal wording changes.
Frequently asked questions
- Does a new brochure always require a new consent form?
- Assess the material information and applicable decisions; document the medical rationale either way.
- Is a distribution email enough?
- It shows dispatch, but targeted acknowledgement and action evidence may be needed to establish implementation.