Beruflich Dokumente
Kultur Dokumente
Protocol Number GCP Inspection Ref. No. CTC Application No. HSA Ref. No. Sponsor Contract Research Organization (CRO) if applicable Contact details of local Sponsor
Phase 3 Phase 4
Site Name Name of Principal Investigator Contact details of Principal Investigator(s) Address: Tel: Fax : Email : Name: Tel: Fax : Email :
Contact details of Clinical Research Coordinator or study staff who will be the main point of contact for logistics arrangements Version No. and / or Date of current Protocol Version No. and / or Date of current Informed Consent Form used at site Version No. and / or Date of current Investigators Brochure
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Study Status
Recruitment status
Ongoing Recruitment closed, subject follow-up only Last patient, last visit completed; data analysis only Suspended Terminated Completed Target : Screened: Enrolled : Randomized : Discontinued: Completed: Study-specific instructions or manuals Organization Chart (applicable for Phase I Units) Signed Signature Sheet of all staff involved in the clinical trial Subject Screen and Enrollment Log Subject Visit Log List of Protocol Deviations for the site Regulatory Document Tracking Log (Annex 1) List of Serious Adverse Events (Annex 2) Other study-specific documents: NB: Please ensure that the enclosures do not contain any subject identifiable information.
Name
Title
Signature
Date
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COMMENTS
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