Module 15 Presentations

10/04/2024

ISO 14155:2020 Annexes

• Annex A (normative) Clinical Investigation Plan (CIP)

• Annex B (normative) Investigator's Brochure (IB)

• Annex C (informative) Case Report Forms (CRFs)

• Annex D (normative) Clinical Investigation Report

• Annex E (informative) Essential Clinical Investigation Documents

• Annex F (informative) Adverse Event Categorization

• Annex G (informative) EC responsibilities

• Annex H (informative) Application of ISO 14971 to clinical investigations

• Annex I (informative) Clinical development stages

• Annex J (informative) Clinical investigation audits

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Remember the Lifecycle of a Clinical Study?

Study Regulatory Approval

Study Design

Study Conduct

Study Close-out

Report

» Determine overall strategy » Develop study design and create protocol

» REC approval » Regulatory agency agreement » Hospital contract » Monitoring plan » DMC » Train investigator and staff » Develop data management process

» Enroll and follow subjects » Collect all data » Address any complications » Monitor data and device use to ensure integrity of data and safety of subjects » Audit

» Compile and analyze data

» Resolve any

pending issues » Retrieve devices » Compile Clinical Investigation report » Dissemination of results » Archive study documents for 10 15years

» Generate reports » Submit report in

regulatory application » Prepare for Inspection

» Statistical » Investigator

qualification and selection

» Manufacture clinical product

» Follow subjects through conclusion of study

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