Health Sciences Authority Health Products Regulation Group

GCP SITE INSPECTION DOSSIER

1. GENERAL INFORMATION Protocol Title

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 of Clinical Trial

Name: Address: Tel: Fax : Email : Phase 1 Phase 2

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

SOP-CTB-CI1.01C Version Date: 30 Sep 2011

Page 1 of 4

Health Sciences Authority Health Products Regulation Group

GCP SITE INSPECTION DOSSIER

Study Status

Recruitment status

Enclosures (please check appropriately)

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.

GCP Site Inspection Dossier submitted by:

Name

Title

Signature

Date

SOP-CTB-CI1.01C Version Date: 30 Sep 2011

Page 2 of 4

Health Sciences Authority Health Products Regulation Group

GCP SITE INSPECTION DOSSIER

ANNEX 1 REGULATORY DOCUMENT TRACKING LOG

REGULATORY DOCUMENT (e.g. Protocol, ICF, IB etc.)

VERSION NO. AND / OR DATE

IRB SUBMISSION DATE

IRB APPROVAL DATE

HSA SUBMISSION DATE (if applicable)

HSA APPROVAL DATE (if applicable)

COMMENTS

SOP-CTB-CI1.01C Version Date: 30 Sep 2011

Page 3 of 4

Health Sciences Authority Health Products Regulation Group

GCP SITE INSPECTION DOSSIER

ANNEX 2 SAE TRACKING LOG SUBJECT ID SERIOUS ADVERSE EVENT ONSET DATE DATE SAE REPORTED TO SITE DATE SAE REPORTED TO SPONSOR / CRO IRB SUBMISSION DATE HSA SUBMISSION DATE COMMENTS

SOP-CTB-CI1.01C Version Date: 30 Sep 2011

Page 4 of 4