Annex 1 clinical trial Application Forms

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Commonly Asked Questions about Annex 1 clinical trial Application Forms

Protocol. Informed Consent Form (ICF) Case Report Form (CRF) Clinical Study Report (CSR) Investigators Brochure. Ethics Committee/Institutional Review Board (IRB) Approval. IRB composition. Insurance statement.
Documents are an integral part of clinical research. Essential documents are those documents which individually and collectively allow the evaluation of the conduct of a trial and the quality of the data generated.
Detailed Curriculum Vitae (CV) and documents/training certificates to ensure that member of the Ethics Committee are conversant with the provisions of the New Drugs and Clinical Trials Rules, 2019, Good Clinical Practices (GCP) Guidelines and other regulatory requirements to safeguard the rights, safety and well-being
Clinical Trial Requirements Consent Form Posting Requirement. Good Clinical Practice Training. Registration and Reporting of Clinical Trial Results.
These documents serve to demonstrate the compliance of the investigator, Sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements. Essential Documents also serve a number of other important purposes.
A Clinical Trial Application provides comprehensive information about the investigational medicinal product(s) and planned trial, enabling regulatory authorities to assess the acceptability of conducting the study.
Annex 1: Clinical trial Application Form. REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR. HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS. COMMITTEES IN THE COMMUNITY.
Dated, documented approval/favorable opinion of IRB of the following: - Protocol and any amendments - CRF (if applicable) - Informed consent form(s) - Any other written information to be provided to the subject(s) - Advertisement for subject recruitment (if used) - Subject compensation (if any) - Any other documents