Prior to study enrollment, the study monitor on behalf of the sponsor will conduct a Site Initiation Visit (SIV) to provide the principal investigator and the study team training on the protocol, procedures, processes and monitoring plan. The monitor will also review the responsibilities of the investigator (21 CFR 312 Subpart D). Supporting ancillary departments that are involved in the study, including the Investigational Drug Service (IDS) also need to participate.
Once the site is initiated, it is important that the research team notifies all parties involved in the study. Internal supporting ancillary departments may require subsequent kick-off meetings to discuss study logistics.
The SIV typically occurs once the site has completed their regulatory requirements (upon IRB approval and contract execution).
Initiation of a site may occur via an onsite visit, teleconference or by attending an Investigator meeting.
Internal Kick-Off Meetings
Clinical Research Unit (CRU)
If you are utilizing the services of the Clinical Research Unit (CRU) for your study, an in-service meeting with the CRU team may be required prior to scheduling services. At the in-service, the study protocol and procedures will be discussed to ensure that all of the elements are in place to safely and effectively begin the study. For more information refer to the web page - Clinical Research Unit (CRU).
A CRU in-service meeting should be conducted prior to scheduling services. The study must be IRB approved before an in-service can be scheduled.
In-service meetings can be scheduled by emailing the CRU.
BioMedical Engineering and Imaging Institute (BMEII)
Depending on the complexity of the study, a kick-off meeting may be required prior to the start of the study to review the workflow with all related parties.
For additional information visit the BMEII Starting a Study page.
A kick-off meeting may be required prior to the start of the study upon completion of the regulatory requirements.
Email Christopher.Cannistraci@mssm.edu to determine if a kick-off meeting is required.
Mandatory Safety Training
MRI Safety Training is mandatory prior to entering the facility.
Investigational Drug Service (IDS)
Investigator Initiated studies that are using the Investigational Drug Service (IDS) are required to schedule a kick-off meeting prior to enrolling subject. Topics to be discussed include institutional logistics, training, IDS workflow.
To schedule a meeting contact IDS.
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