To Use This Template Remove This Heading and Print on Trust Or Practice Letterhead Paper

To use this template remove this heading and print on Trust or Practice letterhead paper, in line with local policy. Ensure the Legend contains all duties required for each study before using this Log.

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke Study Personnel Delegation of Responsibilities

Study Number: Eudract 2013-001185-41 Site ID/Spoke Code: [####]

[SITE NAME]

Instructions: Complete required fields with red text above and delete red, italic text in the header, body, and footer prior to use.

This log should include the Principal Investigator, Co-investigator(s), Primary Study Coordinator, Secondary Study Coordinator(s), Ancillary Biomarker Shipper, Administrator(s), Administrator(s) with Regulatory Requirements, Primary Study Drug/Device Recipient, Secondary Study Drug/Device Recipient(s), and those responsible for any Data Entry, and all other clinical staff who routinely see trial subjects or who have specific data collection/interpretation duties. This log should also include any contracted specialists performing protocol-required examinations. All staff must be authorized for participation by the CRC.

Add new or replacement staff as appropriate. Complete a new line when responsibilities for staff change after the initial delegation.

Print this log template on NHS Trust letterhead paper in line with local policy.

Site ID/Spoke Code can be found in https://webdcu.musc.edu/nett/Network Management/Spoke.

If responsibility “P Other” is used please define responsibilities in the legend below. If there are significant protocol related duties that are not already included in the legend, add additional letters accordingly.

Legend of Responsibilities: A. Overall responsibility for the trial (PI only) I. Study Medication Dispensing B. Informed Consent J. CRF Completion C. Determine eligibility (Inclusion/Exclusion) K. Data Query resolution D. Clinical Assessment L. SAE/Clinical Outcome Event reporting E. Administer NIHSS M. Administer Morisky F. Administer ABCD2 N. Administer QVSFS G. Administer modified Rankin Scale O. Sample Handling and Shipping H. Study Medication Accountability P. Other – Specify: ______

Template v1.0 Page ____ of ____ To use this template remove this heading and print on Trust or Practice letterhead paper, in line with local policy. Ensure the Legend contains all duties required for each study before using this Log.

Q. Review and sign off on source data and CRFs (must T. SAE/Clinical Outcome Event Site Investigator be principal investigator or co-investigator) Review(must be principal investigator or co- R. Prescription investigator) S. Regulatory document maintenance

Study PI Signature Personnel Responsibilities Place an “X” next to the letter that corresponds Start Date and Date Name Study Role End Date (dd-MMM-yyyy) with each delegated responsibility below per the (dd-MMM-yyyy) (dd-MMM- Please print or responsibilities legend. yyyy) type A G S B H T C I D J E K F L A G S B H T C I D J E K F L A G S B H T C I D J E K F L A G S B H T C I D J E K F L

Template v1.0 Page ____ of ____ To use this template remove this heading and print on Trust or Practice letterhead paper, in line with local policy. Ensure the Legend contains all duties required for each study before using this Log.

Study PI Signature Personnel Responsibilities Place an “X” next to the letter that corresponds Start Date and Date Name Study Role End Date (dd-MMM-yyyy) with each delegated responsibility below per the (dd-MMM-yyyy) (dd-MMM- Please print or responsibilities legend. yyyy) type A G S B H T C I D J E K F L A G S B H T C I D J E K F L

The principal investigator should sign below upon conclusion of study activities at this site.

As the Principal Investigator, I maintain full responsibility for this trial and I have delegated significant trial-related duties as detailed above to other appropriately qualified individuals. I have reviewed the information on this log and have found it to be accurate.

Principal Investigator Signature: ______

Date of site closure: ______

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