National Drug Abuse Treatment Clinical Trials Network

Transcription

1 National Drug Abuse Treatment Clinical Trials Network Clinical Coordinating Center at The Emmes Corporation for the National Drug Abuse Treatment Clinical Trials Network NIDA CTN Contract # HHSN C May 19, 2015

2 Discuss who we are and what we do. Define the general purpose of a delegation log. Highlight the challenges to creating one and other elements that a good delegation log should have. Describe the benefits of the new electronic log. Explain the characteristics of the new delegation log and how it is used. 2

3 Multicenter Trials Regional Research & Training Centers (RRTC) Research sites in the U.S. and Canada Clinical Coordinating Center (CCC) Central Regulatory Document Collection Centralized Training and Standardization Central QA, Safety, and Medical Monitoring Electronic Data Capture (Data and Statistics Center)

4 Document allocation of study responsibilities delegated by the Principal Investigator List the research site staff and assigned study roles Reflect staff start and end dates List information specific to the research site (name, date site open to enrollment, etc.) Capture study staff changes as they occur

5 Study Training Plan (Link study roles/responsibilities to protocol-required training) Training Documentation Form (Document/verify training and qualifications) CTN Research Protocol (Study roles/ licensure) Multisite Research Team (Study Roles: PI/Sub-I, Study Physician/Clinician, Other Research Staff) Site Staff Delegation of Responsibilities and Signature Log (Delegated Tasks) 5

6 Study Training Plan (Link study roles/responsibilities to protocol-required training) Training Documentation Form (Document/verify training and qualifications) CTN Research Protocol (Study roles/ licensure) Multisite Research Team (Study Roles: PI/Sub-I, Study Physician/Clinician, Other Research Staff) Site Staff Delegation of Responsibilities and Signature Log (Delegated Tasks) 6

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9 Electronic document using Microsoft Excel Formulas used for autopopulating information 9

10 Standard fields across studies Some room for customization per study Study role linked to: Training criteria based on the Training Plan Documentation expectations Other information captured in the log: Site initiation or activation date Staff training completion, start of study responsibilities, and departure date Investigator of Record for Institutional Review Board communications 10

11 List Site Staff and Licenses (based on study involvement) 11

12 Study Role/Title - Site staff controls this column as titles vary by research site; first two entries hard coded on this page, no other restrictions applied to this column. 12

13 For CCC Internal Use (Autopopulated) Study role and licensure autopopulates First two entries hard coded on the main page of the log for the Site PI and the Sub-I Other staff to be added to log as subsequent entries 13

14 Delegation of Responsibilities grid (SAMPLE): - Responsibilities to be delegated to research site staff (project specific) - Some responsibilities require licensure (MD, PA, NP ) - Staff with oversight must be the PI or Sub-I(s) - Some staff delegated multiple responsibilities X Responsibilities listed above are used as a sample. Delegation log responsibilities are customized for each study. 14

15 License required Delegation of Responsibilities grid (SAMPLE): - Responsibilities to be delegated to research site staff (project specific) - Some responsibilities require licensure (MD, PA, NP ) - Staff with oversight must be the PI or Sub-I(s) - Some staff delegated multiple responsibilities X X X Responsibilities listed above are used as a sample. Delegation log responsibilities are customized for each study. 15

16 No license required; other training maybe required Delegation of Responsibilities grid (SAMPLE): - Responsibilities to be delegated to research site staff (project specific) - Some responsibilities require licensure (MD, PA, NP ) - Staff with oversight must be the PI or Sub-I(s) - Some staff delegated multiple responsibilities X X X Responsibilities listed above are used as a sample. Delegation log responsibilities are customized for each study. 16

17 License required License required X X Responsibilities listed above are used as a sample. Delegation log responsibilities are customized for each study. 17

18 No license required; other training maybe required License required X X X Responsibilities listed above are used as a sample. Delegation log responsibilities are customized for each study. 18

19 Print the form. These columns require written entry after printing the log. No electronic data entry is allowed in this section of the spreadsheet. 19

20 Date TDF Completed - All required training must be completed prior to engaging in study activities. The training completion date is the start date. 20

21 End Date Applied at the close of the site/study or upon staff departure. 21

22 The Site PI will initial and date each entry to verify the listed responsibilities, start date, etc. and indicates a complete entry. 22

23 Standardization and the electronic document worked well Training required for accurate use Some flexibility is necessary for each study Update the template as needed Benefits: Established and accepted network standards Improved investigator oversight and research staff adherence to sponsor requirements Transparent and centralized tracking

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25 Tracee Williams Training Coordinator, Clinical Coordinating Center National Drug Abuse Treatment Clinical Trials Network The Emmes Corporation 401 N. Washington Street, 7th Floor Rockville, MD Phone ext 133 or

26 THANK YOU FOR YOUR PARTICIPATION