Trial Master File (Contents) 1. Front sheet with study title and a list of investigators 2. Protocols i.

Final research protocol and previous amended protocols with version numbers ii. Current and previous versions of subject information materials given to study subjects iii. Copy of the final version of Case Report Form (CRF) and any amended versions iv. Copy of the informed consent agreement signed by subjects v. Curriculum vitae of study investigators 3. Ethics i. Ethics approval letters ii. Any other ethics committee correspondences e.g. amendments trial updates etc 4. Sponsorship i. Copy of study sponsorship agreement ii. Copy of insurance indemnity agreement ! certificate ! letter iii. Copy of financial information relating to the study 5. Documentation on pro uct (!MP) i. "nvestigation #rochure or insert ii. "nvestigational $ew %rug application (if applicable) iii. &hipping logs! records iv. %rug accountability logs v. 'abels e.g. drug label vi. "nstructions for drug prescription vii. Certificate of analysis of study drug ". Stu # lo$s i. (raining logs ii. %uty delegation logs iii. &creening logs iv. Enrolment logs v. )onitoring log vi. "nformed consent log %. Sa&et# i. #lan* safety reporting forms i.e. AEs &AEs ii. +nblinding procedure for blinded studies iii. Record of all reported &AEs and &+&ARs '. (a)orator# i. 'ab documentation forms ii. 'ab normal ranges iii. Copies of calibration certificates

Author: KEMRI-Wellcome Trust Research Programme Version: 22-Oct-2 !

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