Regulatory Knowledge and Support

The role of the “sponsor-investigator” (S-I) may be new to clinical investigators who have spent most of their research career conducting industry-initiated studies. When UMass researchers craft their own protocol for an FDA-regulated trial, this well-known role of investigator shifts to that of a “sponsor-investigator.” Obligations for the S-I, and the institution, require an organized, comprehensive approach to the planning, execution and reporting of such a trial.

The key aims of this Regulatory Knowledge & Support consultation service area are to:

  • strengthen institutional supports for investigators developing their own research protocols
  • enhance knowledge of investigators regarding regulatory pathway for drug, device and biologics-based clinical studies
  • assist investigators in navigating this regulatory terrain by providing ongoing consultation throughout the life cycle of the study
  • promote collaboration in support of these "sponsor-investigators" across the CCTS and the UMass community

All sponsor-investigator studies should be reviewed by Research Integrity and Clinical Operations staff. Ideally, this regulatory review should happen before the IRB submission is written by the researcher, allowing for a stronger submission and a clearer regulatory pathway. This review will assure the sponsor-investigator, the institution and the IRB committee that all regulatory obligations are met, or are being facilitated. Consultation will address, as applicable:

  • Assistance with design and protocol review (consultation with UMass Quantitative Health Sciences) Protocol template for Intervention Trials
  • Completion of FDA Form 1571 and/or 1572 as appropriate
  • Selection criteria and qualifications of all team personnel and associated study sites
  • Education regarding IRB process (initial approval, amendments, continuing review and adverse event reporting)
  • Review direct reporting obligations to the FDA of SAE or unanticipated study problems
  • Creation of Case Report Forms (CRFs) and study documentation tools for consistent use by all research personnel - see REDCap
  • Communication plan (Operations Manual) for all study sites
  • Data safety and monitoring plan (safety officer, full DMC as appropriate)
  • Arrangements for acquisition of study drug and plan for return/destruction of any unused drug; referrals for off-site compounding per protocol requirements.  Referral to Lucie LaJeunesse, RPh, Investigational Drug Service at UMass and UMass Memorial lucie.lajeunesse@umassmemorial.org
  • Registration of study to publicly accessible website, e.g., clinicaltrials.gov, before recruitment is initiated
  • Recruitment and retention planning through local media; and posting investigator-initiated study to ResearchMatch (UMass registration process in progress)

Consistent identification of investigator-initiated studies at the time of IRB submission can lead to improved education of the "sponsor-investigator," better utilization of services and greater enhancement of subject safety and regulatory compliance.  Importantly, it will allow for institutional registration of investigator-held INDs and IDEs, allowing the research integration staff within the UMCCTS to track the reports and communications to the FDA.

Let us help you plan and conduct your clinical trial efficiently and effectively!


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 Benefits

  • Pilot grant programs eligibility
  • Research core services
    at competitive rates
  • Electronic resources access at Amherst libraries
  • Medical School Library access
  • Consultation services
  • Notification of special events and opportunities

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