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- Published
- Updated
- Sources checked
A split dossier needs one controlled view of shared scientific documents and country-specific materials before teams commit to submission.
CTIS Part I and Part II — Define the regulatory scope
CTR Articles 6 and 7 distinguish assessment content. Classify each document by Part I or Part II rather than by the department that happens to prepare it.
CTIS Part I and Part II — Build the working record
Build a country-by-document matrix showing protocol version, consent language, site suitability and reviewer. Add dependencies so that a protocol revision triggers the affected local materials.
CTIS Part I and Part II — Check before release
- Match consent risks to the approved protocol.
- Identify missing country and site evidence.
- Confirm the final upload version independently.
CTIS Part I and Part II — Record the decision and handover
Resolve contradictory versions before release. Record which country package is ready and which remains blocked; Part I-only submission does not remove Part II requirements.
Frequently asked questions
- Does Part I-only replace Part II?
- No. It changes the submission sequence; applicable Part II assessment remains necessary.
- Can one consent translation serve every country?
- Only where the relevant requirements and content permit it; assess country suitability explicitly.