Investigational Product(s): Study Reference: Site: Investigator Name: Site No: Title: First Name: Surname: Title: Responsible Clinical Trials Pharmacist: Pharmacy Address: Clinical Review and Approval Approved/ Initials/Date Received Required Documents Comments (delete as Sponsor Date appropriate) Competent authority notification or 1. EudraCT No./Reference No: approval to conduct study. Yes / NA Approval letter and amendments Approval Date: Ethics Approval Letter 2. Yes Approval Date: R&D Permission 3. Yes Approval Date: Current Approved Protocol (including 4. Protocol Date: Yes amendments) Co-sponsorship agreement 5. Yes Final Signature Date: Technical Agreement(s) if applicable(may 6. Approval Date(s): be multiple) Yes / NA Name of Company: Current UoA policy 7. Clinical Trials insurance in place Yes CNORIS for NHSG Current Investigator Brochure version or 8. Version/date: Yes / NA date of last SmPC update Confirmation that unblinding documents 9. Receipt confirmed Yes / NA are in Pharmacy Confirmation from Pharmacy IMP has been 10. Receipt confirmed received by Site and confirmation of QP Yes release Date of Initiation visit Date: 11. 12. Confirmation Pharmacy has completed set up for this trial and agrees that the trial can proceed Pharmacist Signature: ____________________________________ Date:__________________ GREEN LIGHT Authorisation Date Job Title Name (print) Signature (dd/mm/yy) Research Governance Manager
Investigational Product(s): Study Reference: Site: Investigator Name: Site No: Title: First Name: Surname: Title: Responsible Clinical Trials Pharmacist: Pharmacy Address: Clinical Review and Approval Required Documents Approved/ Received (delete as appropriate) Comments Initials/Date Sponsor Date 1. Competent authority notification or approval to conduct study. Yes / NA EudraCT No./Reference No: Approval letter and amendments Approval Date: 2. Ethics Approval Letter Yes Approval Date: 3. R&D Permission Yes Approval Date: 4. Current Approved Protocol (including amendments) Yes Protocol Date: 5. Co-sponsorship agreement Yes Final Signature Date: 6. Technical Agreement(s) if applicable(may be multiple) Name of Company: Yes / NA Approval Date(s): 7. Clinical Trials insurance in place Yes Current UoA policy CNORIS for NHSG 8. Current Investigator Brochure version or date of last SmPC update Yes / NA Version/date: 9. Confirmation that unblinding documents are in Pharmacy Yes / NA Receipt confirmed 10. Confirmation from Pharmacy IMP has been received by Site and confirmation of QP release Yes Receipt confirmed 11. Date of Initiation visit Date: 12. Confirmation Pharmacy has completed set up for this trial and agrees that the trial can proceed Pharmacist Signature: ____________________________________ Date:__________________ GREEN LIGHT Authorisation Job Title Name (print) Signature Date (dd/mm/yy) Research Governance Manager
UoA-NHSG-TMP-061-V6-Green-Light-Form.docx