CRU-3-04 Study Start-Up Activities

SOP: Study Start-Up Activities
Number: CRU-3-04	Date: Version 2.0, 06/Mar/2026	Supersedes: Version 1.0, 05/Nov/2024	Responsible Authority: CRU Director	Page 1 of 3

1. PURPOSE

   This SOP describes the steps for fulfilling the regulatory and clinical requirements of initiating a research study in the CRU.

2. REVISIONS FROM PREVIOUS VERSION

   2.1Version 1.0, 19Sept2024: Initiation of new SOP.

   2.2Version 2.0, 06/Mar/2026: reviewed the SOP, updated version number and date, added Research Assistant and CRU staff to the SOP.

3. POLICY

   N/A

4. RESPONSIBILITIES

   4.1Principal Investigator (PI) (in collaboration with study funding agency/sponsor, as applicable)

   1. 4.1.1Responsible for ensuring that all participating investigators understand and accept the roles and obligations incurred in undertaking the research study.
   2. 4.1.2Provide a copy of the IRB approved protocol and participant consent forms at the time of access request to the CRU unit.
   3. 4.1.3Responsible for the selection, training, and oversight of research staff.

   4.2CRU Research Coordinator/Research Assistant/CRU staff

   1. 4.2.1Prior to the start of assigned project, the coordinator/assistant/CRU staff member will review the study start-up checklist before, during, and after the study start-up.

5. PROCEDURE

   5.1The PI is ultimately responsible for all procedures but may delegate study start-up procedures. These include the following:

   1. 5.1.1Ensure that all duties of the study have been delegated appropriately according to education, training, and licensure, and that all team members are knowledgeable about their responsibilities (Delegation of Authority form must be filled out).
   2. 5.1.2Verify that all personnel have completed required training.
   3. 5.1.3Ensure that all pre-study activities required by other ancillary service providers have been completed.
   4. 5.1.4Order any supplies needed for the study that have not been provided by the sponsor.
   5. 5.1.5Confirm that reserved space for conducting research visits, storage of study related materials, and equipment have been prepared.
   6. 5.1.6Develop or utilize sponsor-generated worksheets, checklists, flow sheets, and SOPs to assist study personnel with study conduct.
   7. 5.1.7Confirm that the contracts have been fully executed (check with Sponsored Programs).
   8. 5.1.8Review study procedures with assigned study staff.
   9. 5.1.9Ensure that all regulatory documents are complete, up-to-date, and filed in the regulatory binder.

   5.2The Research Coordinator/Research Assistant/CRU staff will ensure the following is executed and completed:

   1. 5.2.1Request a start-up checklist from the study PI/sponsor or create a checklist for the study start-up if needed.
   2. 5.2.2Establish a suitable date and time for site start up review and make sure key personnel are available.
   3. 5.2.3Assure study personnel are familiar with all study materials (e.g. protocol, investigator brochure, CRFs etc.) in advance of study start.
   4. 5.2.4If there is a study Monitor assigned to the study:
      1. 5.2.4.1Request an agenda from the Monitor or create one for the start-up visit.
      2. 5.2.4.2If needed, provide the Monitor with directions and assistance identifying nearby accommodations.
   5. 5.2.5Ensure IRB Approval has been obtained or review is in process. IRB approval must be received before the study can start.
   6. 5.2.6During Site Visit or Study Review:
      1. 5.2.6.1Ensure that the PI is present.
      2. 5.2.6.2Review details of the protocol, including study operations, with the Monitor (if applicable) or study personnel.
      3. 5.2.6.3Discuss with PI or Monitor which key personnel are authorized to perform what study-related functions or procedures.
      4. 5.2.6.4Document operational questions not covered in the protocol and the answers provided by the PI/Monitor or Sponsor.
      5. 5.2.6.5Discuss test article administration and accountability (if applicable).
      6. 5.2.6.6Review instructions on study-specific activities, such as diagnostic tests, lab kits, or study-required software and any related recordkeeping requirements (e.g. temperature logs, calibration logs etc.).
      7. 5.2.6.7Review directions for source documentation and/or CRF completion.
      8. 5.2.6.8If applicable, review required source documentation and the documentations that is to be provided at future monitoring visits.
      9. 5.2.6.9Discuss applicable study-related specific training involving protocol execution (e.g. in-service for research nurse, physician investigator).
      10. 5.2.6.10Provide the PI or Monitor with an update on any study-related issues.
      11. 5.2.6.11Identify important PI, Sponsor or Monitor contacts and corresponding time frames (e.g. enrollment logs, safety reporting).
   7. 5.2.7Following the site visit or study review:
      1. 5.2.7.1File all training certificates or logs in the regulatory binder and credentials binder, if applicable.
      2. 5.2.7.2Document the Site Visit or Study Review in the dedicated Site Visit/Study Review Log and file in regulatory binder.
      3. 5.2.7.3Ensure receipt of written documentation summarizing important agreements made during the visit/review (such as sponsor follow-up letter, if applicable).
      4. 5.2.7.4Assemble screening and enrollment materials.
      5. 5.2.7.5Activate enrollment plan once IRB and sponsor approvals are obtained.

6. MATERIALS

   Study Start-up Checklist
   Group Training Documentation

7. REFERENCES

   N/A

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SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

Executed signature pages are available in the Initiating Authority Office

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