Module 5 Presentations

05/07/2024

Adapt to new submission options and limitations

Initial CTA submissions • Part I only (i.e. no country level information yet available other than confirmed country list) • Part I + Part II for all countries (all country-specific docs to be available for this) • Part I + Part II for some countries (other countries to be submitted later as additional Part II) • Part II only (after previous ‘Part I only’ submission approved) Additional Member State submission • Part I + Part II CTR prevents concomitant / overlapping assessment of more than one substantial modification (part I and or part

II) in a given country at any given time, hence minimization of amendments will be critical => Probably one of the most significant operational impacts to consider for maintenance of programs

Substantial modification submissions • Part I only • Part II only • Part I + Part II

Non Substantial Modifications (NSM)

any part any part

NSM relevant for the supervision of the clinical trial (CTR, Art.81.9)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

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Transparency related

• Need to avoid redaction efforts to a miminum set of documents in a Clinical Ops environment

Documents to be published

• Documents now published are limited to Protocol, Protocol synopsis, Patient Documents (Part I and Part II), Recruitment arrangements • Personal information will be more around Authors/Approvers, contact details, signatures => Need for optimized redaction methodologies allowing for « just in time » management of redaction in a context of short timelines i.e. answer requests for information (12 days)

Protect CCI

Protect PPD

« Transparency by design » Review processes and document creation to minimize amount of PPD / CCI to be processed downstream

Adaptations to document Authoring

Targeted redaction processes

Use publication deferral rules

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

48