| Protocol Title: | IND/IDE# |
| IRB Number: | Sponsor: UAMS |
| Site: | Principal Investigator: (PI) |
| Study Personnel (Print Full Name) | Study Role (e.g. PI, Sub-I, Coordinator, Regulatory) | Authorization Code(s) (See Legend) | Start Date | PI Initial and Date | Stop Date | PI Initial and Date | Staff Initials | Staff Signature and Date |
| Authorization Code Legend: 01: Obtain informed consent 02: Informed consent process note 03: Conduct subject interviews 04: Obtain/review medical history 05: Eligibility assessment 06: Perform physical exam 07: Randomize subjects 08: IP administration 09: IP dispensing 10: IP accountability 11: AE/SAE/UPIRTSO assessment 12: AE/SAE/UPIRTSO reporting 13: Complete source documents 14: CRF completion and query management 15: CRF signature 16: IRB Submissions 17: Maintain IRB submissions 18: Maintain regulatory docs 19: Collect data 20: Laboratory specimen collection 21: Process sample specimens 22: Ship hazardous material 23: Concomitant medication review 99: Other: ________________________ |
| Principal Investigator’s Authorization: I hereby delegate the above significant research–related duties to the aforementioned staff members and certify that they are trained and qualified to perform the specified duties for the protocol listed above. All research procedures related to treatment are conducted within UAMS by licensed and certified clinical staff. I understand that the overall responsibility of conduct of the research remains with me. PI Print: PI Signature: PI Initials: Date: |