Form Y Monitoring Plan - Lead PI
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FORM Y HUMAN USE RESEARCH Monitoring Plan – Coordinating Center and/or Lead PI IRB # HSC20------
This document explains in detail the monitoring plan for the Coordinating Center and/or Lead PI to oversee the entire study. It is divided into four major sections: 1) Monitoring IRB approvals, 2) Monitoring of Modifications, 3) Problem Management, and 4) Communication.
Primary and Secondary (off-site) PI:
Lead PI: Secondary Lead:
Monitoring IRB and Institutional approvals Insert answers to each separately. Add text below the box as necessary to completely respond to this concern.
1. Describe plan for obtaining copies of other sites IRB or Institutional approval letters (state frequency of reporting, method of reporting and party at site responsible for this reporting by name or title, plan for advising sites of upcoming deadlines and pending expirations)
Insert PI response here
2. Describe plan to ensure that no study activity is initiated at any of the sites before IRB and Institutional approvals are secured
Insert PI response here
3. Describe plan for collecting data from each site as part of the continuing review process. Identify how lapses in IRB approval at individual sites will be handled.
Insert PI response here
Monitoring of Modifications Insert answers to each separately. Add text below the box as necessary to completely respond to this concern.
1. Describe who (sponsor, lead PI, etc.) is authorized to make modifications to the protocol documents (sponsors protocol, model consent, etc.)
Insert PI response here
2. Describe plan for updating sites with modifications to the protocol documents (sponsors protocol, model consent, etc.) (Include frequency and method of communication)
Insert PI response here
3. Describe plan for ensuring sites implement modifications in accordance with federal and local regulatory requirements (Include frequency and method of communication)
Insert PI response here
4. Describe plan for communicating when data collected and/or enrollment is halted pending approval of an amendment (i.e. UPIRSO/UADE)
Insert PI response here
5. Describe plan for how sites will request modifications to the protocol documents (sponsors protocol, model consent, etc.) (Include timing of initiation and Lead PI being aware of the change as well as methods of communication; account for UPIRSO/UADE internal to the other site which may require immediate action to protect the health and welfare of subjects at the other site as well as how this is handled for the remaining sites)
vMay 2016 Page 1 of 2 FORM Y HUMAN USE RESEARCH Monitoring Plan – Coordinating Center and/or Lead PI IRB # HSC20------
Insert PI response here
Problem Management Insert answers to each separately. Add text below the box as necessary to completely respond to this concern.
1. Describe plan for ensuring Lead PI is aware of any problems at the other sites (include frequency and methods of communication)
Insert PI response here
2. Describe plan to assess problems (e.g., in relation to: risk to the study participants or others, effect on study at a national level or solely affecting a study site at a local level, effect on scientific integrity of the study, effect on study’s protocol)
Insert PI response here
3. Describe plan for assisting sites in handling problems (tracking by Lead PI, Lead PI consulting on problems, a priori instructions to sites concerning handling of problems)
Insert PI response here
Communication Insert answers to each separately. Add text below the box as necessary to completely respond to this concern.
1. Describe multilevel communication plan (Including if applicable: Periodic Research Meetings involving all research staff (including frequency, expected major agenda items and likely/required (if any) attendees)
Insert PI response here
2. Describe multilevel communication plan (Including if applicable: Project Coordinators’ Meetings (including frequency, expected major agenda items and likely/required (if any) attendees)
Insert PI response here
3. Describe multilevel communication plan (Including if applicable: Executive Committee Meetings (including frequency, expected major agenda items and likely/required (if any) attendees)
Insert PI response here
4. Describe multilevel communication plan (Including if applicable: Database Training Meetings (including expected frequency, major topics and likely/required (if any) attendees)
Insert PI response here
5. Describe multilevel communication plan (Including as applicable: How current regulatory documents are made available to all sites.
Insert PI response here
6. Describe multilevel communication plan (Including as applicable: Site Visits (including frequency, expected inspection points (indicate whether activities will include solely administrative issues or also medical monitoring) and likely/required (if any) interviews)
Insert PI response here
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