Cancer Center Clinical Trials Office

Transcription

1 Cancer Center Clinical Trials Office STANDARD OPERATING PROCEDURE DOCUMENTING DELEGATION OF AUTHORITY SOP#: Original Approval Date: 7/14/17 Version#: 2.0 Current Revision Date: 2/20/ PURPOSE/BACKGROUND The local Principal Investigator (PI) is responsible for ensuring that only individuals qualified by means of education, training and experience are charged with the authority to perform researchrelated tasks. FDA regulations require the Principal Investigator (PI) to personally supervise the conduct of research under his/her name. However, delegation of research-related tasks allows other individuals to actively participate in the implementation and conduct of research. While authority to perform specified tasks may be delegated, the responsibility for those tasks always remains with the PI. 2.0 SCOPE This SOP applies to all studies managed by the MCW Cancer Center Clinical Trials Office (MCW CCCTO). 3.0 RESPONSIBILITY Study Principal Investigator (PI) Sub Investigators Pharmacy Others as assigned 4.0 DEFINITIONS Refer to Glossary of Common Terms and Definitions Master Signature Log (MSL): Log containing all signatures of any person assigned to work on any human research study managed by the MCW CCCTO. Central Delegation Key: A list of all duties that study staff are authorized to perform based on their role. Protocol-Specific Delegation of Authority Log (PS-DOA): A typed list of staff designated to work on a specific trial, along with any protocol specific tasks beyond what has been listed on the Central Delegation Key. 5.0 ROLES AND PROCEDURES SOP Documenting Delegation of Authority v2.0 Page 1 of 4

2 Cancer Center Clinical Trials Office 5.1 Delegation of Authority will be documented for all studies managed by the MCW CCCTO. With assistance from the regulatory staff, delegation will be documented using a combination of a Master Signature Log and separate Protocol-Specific Delegation of Authority Log (see appendix 1 & 2). Sponsor provided delegation logs will not be used. 5.2 Prior to beginning research-specific tasks, those assigned to play a significant role in research on any trial within the CCCTO will sign the MSL. At time of signature, the study staff member must review the Central Delegation Key (appendix 3) and acknowledge the tasks in which they have been delegated A significant role is described as one who may perform an activity regulated by the FDA such as informed consent, assessment of the primary endpoints, attribution of adverse events, etc. Nurse Practitioners, Physician Assistants, clinic nurses, and infusion nurses will not be added to the MSL or PS-DOA log (unless they are delegated to perform activities regulated by the FDA), since they work under the supervision of the Principal Investigator or a Sub-investigator. 5.3 The PS-DOA Log will contain a typed list of all study staff members as well as any additional duties not contained on the Central Delegation Key. Specific duties will not be added to the PS-DOA Log if they are already listed in an equivalent form on the Central Delegation Key. 5.4 The regulatory staff will add the specific team members to the corresponding PS-DOA log. Any edits made to the PS-DOA should be typed. If a staff member is delegated to perform a duty that is not listed on the Central Delegation Key, the staff member will be informed. 5.5 The PI must officially approve any delegates by signing and dating applicable pages of the PS-DOA log. All versions of the PS-DOA will be stored in the regulatory file. 5.6 The PS-DOA log will be reviewed periodically to assure that it is kept up to date. If change to the study staff or their delegated duties are made, the log will be updated accordingly and re-signed by the PI. 5.7 When a study closes or when individual participation in the study ends, end dates will be recorded appropriately on the PS-DOA log. An updated investigator signature will not be obtained for a staff end-date-only change to the PS-DOA log. A final PI signature will be obtained when the study ends. 5.8 The original MSL will be filed securely in the regulatory office. The PS-DOA log will be housed in the corresponding study regulatory file. Both documents will be scanned into the shared electronic drive. 5.9 The MSL will routinely be shared with sponsors, monitors, and auditors in an electronic or photocopied paper format due to the invaluable nature of the original document. The original document with wet-ink signatures may be viewed in the regulatory office upon request SOP Documenting Delegation of Authority v2.0 Page 2 of 4

3 6.0 REFERENCES Cancer Center Clinical Trials Office Guidance for Industry Investigator Responsibilities Protecting the Rights, Safety, and Welfare of Study Subjects. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) and E6 Good Clinical Practice (GCP) 21 CFR Subpart D Selecting Investigators and Monitors 7.0 APPENDICES Appendix 1: Master Signature Log (MSL) Template Appendix 2: Protocol Specific Delegation of Authority Log (PS-DOA) Template Appendix 3: Key - Centralized Delegation of Tasks for SOP Documenting Delegation of Authority v2.0 Page 3 of 4

4 Cancer Center Clinical Trials Office Authorized by: James Thomas, Medical Director Betty Oleson, CTO Administrative Director Revision dates: 7/14/17, v 1.0 2/20/18, v 2.0 Review dates: 2/20/ SOP Documenting Delegation of Authority v2.0 Page 4 of 4

5 Master Signature Log For use with central delegation key and protocol-specific delegation log. Name (Print) Signature Handwriting Sample Sample Example Sample Example The quick brown fox jumps over a lazy dog Acknowledgement of delegated task (Initial & date) SE 5/1/17 Template Version July 14, 2017 Page of

6 Protocol-Specific Delegation of Authority Log For use with central delegation key and Master Signature Log. PI Name: Protocol Title: Sponsor: Site Name: NAME Full Name ROLE, NP, PA, Research Nurse, Pharmacist, Clinical Research Coordinator, etc. (Per Key) PROTOCOL-SPECIFIC TASKS START DATE END DATE 1,2,3,4,5,6,7,8,9,10 01/JAN/ /DEC/ Protocol-Specific Tasks (Not listed on Key) I authorize the individuals listed to participate on this protocol and perform the tasks delegated on the central delegation key and as indicated above. PI Signature: Date: Template Version July 14, 2017 Page of

7 Key - Centralized Delegation of Tasks for This document describes the standard research tasks delegated to each role within the MCW Cancer Center Clinical Trials Office. Individuals are delegated the authority to perform the tasks appropriate for their role, as indicated below, unless otherwise noted on a protocolspecific delegation of authority log. Please note: this key may not be all-inclusive; roles not captured here should be listed on the protocolspecific delegation of authority log. Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Assessment of inclusion/exclusion criteria Initial documentation: Requires evidence of confirmation by, before subject registration Research Nurse (RN), Coordinator, & Manager GENERAL ACTIVITIES Initial documentation; Requires evidence of confirmation by, before subject registration Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory Informed consent/assent, only when approved by the IRB Vital signs (Height, weight,, under supervision of, as certified by institution. BP, Pulse, RR, temperature, Pulse ox) physician investigator. Assess Performance Status, Research Nurse Only Physical exams, under supervision of physician investigator. Medical history, under supervision of physician investigator. No Clarifications only; Medically focused evaluations done by /PA/NP, medication review only (Pharmacist only) No No No Orders for test article No No CTO Laboratory Version: July 14, 2017 Page 1

8 Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Administration of test article Dose Limiting Toxicity determination Maximum Tolerated Dose determination Dose modification (including reductions, holds or restarts) Intake/documentation of symptoms Assessment of grade using CTCAE Transcription of grades from CTCAE for abnormal laboratory results Assessment of clinical significance of labs, in conjunction with overall PI., under supervision of physician investigator. Initial assessment; Requires Initial assessment; Requires Overall PI Initial assessment; Requires Research Nurse (RN), Coordinator, & Manager No (possible exception made for research nurses in rare cases) Initial assessment; Requires Initial assessment; Requires Overall PI Initial assessment; Requires Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory Initial assessment; Requires evidence of confirmation by (Pharmacist only) No No No ADVERSE EVENTS, under supervision of physician investigator. Initial determination; Requires, NP or PA No No No, based on if action was taken because of lab value. No, based on if action was taken because of lab value. No CTO Laboratory No Version: July 14, 2017 Page 2

9 Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Assessment of expectedness Assessment of relationship to test article (i.e., attribution/causality) SAE determination (i.e., event meets criteria for expedited reporting) Research Nurse (RN), Coordinator, & Manager No Initial determination; Identification based on current version of Investigator Drug Brochure; Requires evidence of confirmation by. Initial determination; Requires evidence of confirmation by, under supervision of physician investigator. Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory Initial determination; Requires No If pre-specified in No No protocol; Otherwise requires evidence of confirmation by Report to sponsor as SAE No CTO Laboratory Documentation of accountability and adherence by review of subject diary Documentation of accountability and adherence by count of test article returned by subject DRUG/DEVICE No No No No No Version: July 14, 2017 Page 3

10 Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Drug/device receipt from the sponsor, storage, preparation, dispensation, destruction, unused returns to the sponsor, and related documentation Writing in subject s medical record or research chart Research Nurse (RN), Coordinator, & Manager Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory No No No No No No SOURCE DOCUMENTS No No STUDY PROCEDURES Subject Randomization CTO Laboratory Lab sample processing, shipping or receiving Evaluation of response results Assessment of primary study endpoints Physical assessments, cognitive tests (i.e. walk tests, strength tests, measurements, neurocognitive tests, etc.) No No No Initial determination; Requires evidence of confirmation by Initial determination; Requires evidence of confirmation by Initial determination; Requires Initial determination; Requires Version: July 14, 2017 Page 4

11 Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Research Nurse (RN), Coordinator, & Manager Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory Subject photography Subject Questionnaires, Patient Reported Outcomes IVRS/IWRS access No, for No No No pharmacy functions Perform EKGs/ECGs on, with documented provided training. REGULATORY DOCUMENTS Maintain regulatory binder or essential documents, pharmacy specific documents CASE REPORT FORMS (CRFs), pharmacy specific forms No CTO Laboratory Data transfer from source documents to CRF No, study lab specific forms. Sign completed CRF No No Data query resolution No, pharmacy No No specific forms COMMUNICATIONS Communications and submissions to sponsors, IRB, or federal authorities, and Froedtert & MCW No Version: July 14, 2017 Page 5

12 Research Tasks Physician Assistant (PA) / Nurse Practitioner (NP) Directly supervise Clinical Research Assistants, Coordinators, & Research Nurses. Research Nurse (RN), Coordinator, & Manager No No, Manager only. Pharmacist, Pharmacy Assistant/Tech Assistant Regulatory CTO Laboratory Version: July 14, 2017 Page 6