Liaison: Provides support to the Supplemental Methodological Study (SMS) Principal Investigator by serving as liaison between the Supplemental Methodological Studies Investigator(s) and the National Children’s Study Program Office staff.
- Facilitates communication between the SMS Principal Investigator/applicant and the National Children’s Study during both the application process and implementation
- Facilitates communication with the Program Office, including but not limited to data access, publication, and specimen and sample access.
Advocate: Assumes accountability as an advocate for the National Children’s Study.
- Assures that the SMS burden to National Children’s Study participants and Study infrastructure does not exceed that which was proposed and approved.
- Assures the process throughout the SMS implementation is as was approved.
- Assures that the actual use of biospecimens and environmental samples is as was approved in the review process.
- Assures continued compliance with the relevant National Children’s Study policies and agreements, such as those pertaining to data use, publications, specimen/sample/repository use, and other agreements.
- Oversees, facilitates, and assures the timely development and implementation of the approved SMS, informing the Program Office Supplemental Methodological Studies Team of any inability to initiate the SMS within the anticipated and approved timeframe.
- Notifies the Program Office Supplemental Methodological Studies Team if the project is not progressing according to plan or is discontinued for any reason.
- Assures that the Supplemental Methodological Studies Team receives a periodic progress report from the SMS Principal Investigator regarding the status of the initiated SMS. Such reports are required at completion of the SMS, annually if the SMS extends over a year, and as requested by the SMS Team.
- Assures that appropriate documentation regarding continued IRB approval is provided to the Program Office IRB Team.
A signed National Children’s Study Co-Investigator/Facilitator Agreement Form (PDF 48 KB) must be submitted prior to final approval of an SMS.