ORC Monitoring for IND/IDE studies
The purpose of clinical trial monitoring is to verify that the rights and well-being of human subjects are protected, the reported trial data are accurate, complete and verifiable from source documents and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, SOPs and with applicable regulatory requirements such as the FDA, state laws, and NSLIJ policies and procedures.
The Regulatory Affairs Division of the ORC offers fee-for service monitoring for investigators that hold an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) with the FDA. Services are offered for single or multi-site studies and fees are structured based on proposed number of sites and subjects enrolled.
- Routine or targeted monitoring according to the risk based monitoring plan
- Exit meetings with the site Principal Investigator and study team
- Generation of monitoring reports that are sent to the Principal Investigators and sites
- Customized training through one-on-one education, small group sessions, in-services, protocol initiation visits, or IND/IDE sponsor trainings
Using the protocol and clinical trial monitoring plan, our monitors are able to conduct periodic, ongoing review of subject records and regulatory documents including:
- Confirmation of subject eligibility
- Documentation of informed consent
- Protocol adherence
- Data collection and quality
- Source documentation review
- Study drug/device management and accountability
- Adverse event review and reporting obligations
- Compliance with sponsor-investigator obligations including IRB and FDA reporting responsibilities
Types of Monitoring Activities
Site Initiation Visits (SIV)
The SIV usually occurs after the site has completed all regulatory requirements and has obtained IRB approval for the research study at their site; it is the last step before the study site is activated for enrollment by the sponsor. During an SIV the research study team receives adequate training from the sponsor on the protocol. It is also the opportunity for the sponsor to ensure that the investigator fully understands his/her responsibilities. ORC Monitors will provide training as part of the SIV and works collaboratively with the sponsor-investigator on developing the content. During study start-up, a sponsor may choose to hold an investigator meeting for a large number of sites in lieu of conducting many site initiation visits.
Other topics discussed during the SIV include:
- Study overview, eligibility criteria, procedures, access to suitable patient population
- Lab manual, requirements for research sample processing and shipping
- Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, IRB obligations, adverse event and data safety monitoring reporting,
- Investigational product (e.g. drug or device) accountability and management
- Data forms review including Case Report Forms (CRFs) and data management
- Regulatory documents and study file organization
- 21 CFR 312 Subpart D & 21 CFR 812 Subpart C & E Responsibilities of Sponsors and Investigators and other relevant regulations
- Standard Operating Procedure (SOPs) or Manual of Procedures (MOPs)
Periodic Monitoring Visits
The ORC in collaboration with the sponsor will develop a monitoring plan that includes the frequency and duration of periodic monitoring visits. The focus of these visits is to evaluate the way the study is being conducted and to perform source document verification.
Sites preparing for a monitoring visit will need to do the following:
- Complete all necessary CRFs
- Confirm that safety monitoring reports (e.g. Serious Adverse Event (SAE) forms, DSMB/DMC) have been submitted and are available for review
- Obtain source documents, such as medical records for the CRFs to be reviewed against
- Organize study file documents (e.g. regulatory and subject files) for review
- Confirm that signed consent forms for all enrolled participants are available
- Schedule an appointment for the monitor to visit the pharmacy or location of where devices are stored
- Schedule a time for the PI & study coordinator to meet with the monitor towards the end of the visit to review findings.
When the research study has been completed at a site, a close-out visit occurs. Some close-out visits are also combined with a final periodic monitoring visit.
Action items during the close-out visit may include:
- Return or destruction of investigational product
- Collect outstanding patient data forms and study forms
- Perform a final review of the study file documents
- Discuss timelines and strategies for the completion of outstanding case report forms and data queries
- Discuss the plans for record retention
- Discuss ongoing investigator responsibilities
Obtain a Quote
Contact the ORC to obtain a quote for monitoring services at (516) 465-7940 or firstname.lastname@example.org
Quotes can be provided at the time of budget submission for grants and contracts. Protocol information, number of sites and subjects to be enrolled are needed to provide an estimate.
QA & Monitoring Team
AVP: Emmelyn Kim, MA, MPH, CCRA, CHRC
Clinical Research Monitor: Sharon Hochman, MA