Page 52 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-003 Title: Initiating the Research Laboratory &
Approval Process
collection, processing, storing, and shipping. They are essential for providing a chain of custody and are subject to audit and used to validate the data on a clinical trial.
5. SPECIFIC PROCEDURE
5.1 Lab Feasibility & Approval: In line with the study start-up process (see R001), feasibility assessments can be completed prior to securing a study funding agreement in observation of Policy CP: 7.12 Responsibilities of a Research Team.
5.1.1 Upon receiving a CTS request, the CRC should work with their Team Lead (TL) to complete the Lab Feasibility Questionnaire. Some information may not yet be known. At which point, it can be communicated that more information is forthcoming.
5.1.2 The CRC should turn the protocol, lab manual, and supporting documents along with the Laboratory Feasibility questionnaire completed as fully as they are able (with support of PI or ancillary team to help provide clarity on process) to Lab Reviews should
be submitted to Lab.Review@childrens.com and cc: Matt Quintero (Elias.Quintero@childrens.com) (see SOP Overview of Study Start-Up).
5.1.3 Upon review, the lab will appraise the needs of the study and request additional information or clarification whenever possible. The CRC and TL should respond to the queries in a timely way.
The Lab will approve, deny, or approve with stipulations. The TL and CRC should eb mindful of these stipulations and make arrangements to cover the study and prepare logistics. The lab may approve some parts of the lab procedures, but not others, or put limits or constraints. For example, approved for “<3 subjects a week,” “no after-hours processing,” or “No complex spin-and-holds after hours,” etc. Please, an example of the Lab Approval letter and file it in the regulatory binder.
5.1.4 Please, note that any protocol amendments that modified the lab procedures would require a modification to the lab approval. The CRC should initiate the steps 5.1.1-5.1.3 providing the principal investigator (PI) last name, lab approval letter, number, and IRB number.
5.1.5 Upon confirmation of the study assignment and securing a study funding agreement, the CRC can then continue with drafting the Lab Requestions sheets as outlined in section 2.
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