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Back in April of this year, the lab research team presented an overview of newly adopted processes for research studies requiring lab support. A lot of information was given on that day. This is written to offer a quick summary of the lab review process, the purpose of this letter [KK1] and how this all fits into the Performance Site Approval (PSA) at Children’s Health℠.
The Lab Review Process
Laboratory Research Support Required?
Whenever a new study is submitted for IRB review and PSA, the Principal Investigator, study coordinator or other similar designee should notify the lab of the pending study by reaching out to LabResearchAdmin@Childrens.com. The following information should be provided:
The lab will review all documents to verify all requested services. If a study requires complex resources, the Lab Research Administrator will determine if the study should be reviewed by the lab’s Research and Development Committee to resolve study logistics and all applicable charges. Once all issues have been addressed, the lab will send a study-specific approval number to the study team. A Notice of Laboratory Research Services Approval letter will also be issued to both the study team and Children’s Research Administration. This letter will itemize all lab services that will be provided for the study and will be signed by the Lab Medical Director and the Director of Laboratory Services. You do not need this letter in hand to continue along the Performance Site Approval Process at Children’s.
How the Lab Review Fits into the Children’s Performance Site Approval
The lab review process is in place to ensure that all requested services in support of a study can be accommodated. If any concerns are identified, the lab will work with the study team to resolve them in the most efficient and cost-effective way. Therefore, the lab review complements the institutional PSA process. During the PSA review, Children’s Research Administration will verify their findings with what the lab review process has included in the lab research support letter issued for that study. This will help with the study cost analysis and execution of the Service Order Agreement, if applicable. Once the PSA has been issued, investigators can proceed with all study activity, including any required services referenced in the lab research support letter.
I hope this summary brings some clarity to the lab research review process. If you have any questions, please don’t hesitate to reach out to any of the following team members:
Matt Quintero Ext. 6-6146 Matt.Quintero@Childrens.com
Lab Research Administrator
Amanda Cortinas Ext. 6-2612 Amanda.Cortinas@Childrens.com
Lab Clinical Research Specialist
Oscar Molina Ext. 6-6158 Oscar.Molina@Childrens.com