Page 401 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Study Title:
IRB #:
Principal Investigator: Date:
Note to File
Re: Delegation of Authority Log
This Note to File (NTF) serves as official communication regarding Children’s practice as it pertains
to lab personnel and the Delegation of Authority (DOA) log.
Consistent with Good Clinical Practice (GCP) section 4.1.5, our lab personnel and lab director are considered ‘non-research’ staff as they do not perform significant trial-related duties; and the duties they perform are within the scope of their usual practice and do not require study specific training. As such, no lab personnel will be noted on the DOA for lab processing and shipping. Our lab is fully CLIA and CAP certified and perform research-related services commensurate with these certifications.
Even though the Federal Regulations (21 CFR 312 and 812) are silent on DOAs, to bridge the gap between what the regulations require and many sponsors’ needs, we include this NTF in study documents explaining our decision to not list said personnel on the DOA.
Also, in line with GCP guidelines, all research related samples processed at our site will be documented on study-specific lab instruction sheets completed by the study team, which will capture the date and time the samples were collected, processed, stored and shipped. The lab instruction sheets will inform the study specifications outlined in the protocol, manual of operating procedures, and/or laboratory manual(s) for a given study. All required infrastructure and staffing required for study sample collection and processing will be confirmed by the laboratory personnel. Each study will also be issued a lab approval letter, which will outline all services to be performed by lab personnel and will be signed by the Medical Director of the Lab and the Director of Laboratory Services. This lab approval letter is the study-specific documentation attesting that all lab personnel providing services to the study have the appropriate qualifications and the study-specific training necessary to properly do so. A blank copy of the lab approval letter should be attached to this NTF. No study requiring lab services is approved to start without the lab approval letter.
Calibration records and inspection reports for all relevant laboratory equipment will be made available upon request. Additionally, temperature monitor reports are archived and can be made available upon request.