Julius Centrum voor Gezondheidswetenschappen
en Eerstelijns Geneeskunde / Bureau Kwaliteitsborging Onderzoek /

Contents Study Master File

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  1. Contact Information Study

  1. Regulatory and Ethical documents

  1. Central Approval, Competent Authority approval (no appeal). Incl. submission letters and list of Ethical Committee members.

  1. EudraCT Application Form

  1. ABR form

  1. Progress report for Central Ethical Committee

  1. Correspondence Central Ethical Committee

  1. FDA form

  1. Financial Contracts / Signed Agreements

  1. Project Plan

  1. Clinical Study contract with sponsor

  1. Other agreements (pharmacy, laboratory, CRO etc.)

  1. Study Protocol

  1. Protocol

  1. Amendments

  1. Participant Information

  1. Approved (central) version(s) of Participant Information Form and Informed Consent

  1. Other written information given to the participant (e.g. news letters, diaries, appointment cards etc.)

  1. Advertisements used for recruitment

  1. Subject Screening and Enrolment Log (example)

  1. Subject ID code list (example)

  1. Subject compensation forms

  1. Insurance

  1. Participant insurance (overall)

  1. Liability insurance (overall)

  1. Monitoring / Audit / Inspection documents

  1. Monitoring Visit Log

  1. Monitoring Plan

  1. Overview performed monitoring visits

  1. Audit / Inspection report(s) / letter(s)

  1. Working Procedures

  1. Monitoring manual

  1. Investigator / site manual

  1. Randomisation procedure

  1. Archiving manual

  1. Other manuals / protocols

  1. Product Information / Pharmacy

  1. Drug accountability form / Drug dispensing log (example)

  1. Decoding procedures

  1. Temperature log (or at pharmacy)

  1. Investigator Brochure (IB) / Investigational Medicinal Product Dossier (IMPD) / SPC

  1. Labelling of study medication

  1. Trial receipt (example; if not filed in the Center and Investigator Master File)

  1. Instruction for handling investigational product

  1. Shipping records for investigational products (or at pharmacy)

  1. Certificate of analysis of investigational product (or at pharmacy)

  1. Import licences (or at pharmacy)

  1. Drug destruction forms (example)

  1. Central Lab

  1. Accreditation / certificate

  1. Normal ranges

  1. Safety

  1. Safety report guidelines (e.g. SUSAR flow)

  1. Example SAE form

  1. Safety reports (incl. line-listing)

  1. General correspondence regarding safety to investigators

  1. Correspondence regarding safety with investigator and sponsor

  1. Correspondence regarding safety with Ethical Committee, Competent Authority, Medicines Evaluation Board (CBG)

  1. DSMB report

  1. Case report Form (CRF)

  1. Empty CRF

  1. Guidelines

  1. File Notes

  1. Protocol Violation Forms (example and completed forms, incl. line-listing)

  1. Note to File (example and completed study specific notes)

  1. Documents of meetings

  1. Investigator meeting (incl. signature log)

  1. CRA meeting (incl. signature log)

  1. Training, etc. (incl. signature log)

  1. Record of retained body fluids / tissue samples (overview sites)

  1. Clinical study report / Manuscript / Publication

  1. Other

  1. General templates (example) (e.g. Authorisation Signature Sheet)

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Checklist_Study Master File_Version 3_5 mei 2009