Committee Committee Overview amp Process for Investigators Updated as of May 18 2020 COVID19 Clinical Trials Review Committee Membership Charge Criteria for Evaluation Process Overview ID: 1043787
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1. COVID-19 Clinical Trials Review CommitteeCommittee Overview & Process for InvestigatorsUpdated as of May 18, 2020
2. COVID-19 Clinical Trials Review Committee MembershipChargeCriteria for EvaluationProcess OverviewReview DecisionsInvestigator Submission RequirementsContact Information2Contents
3. Constance A. Benson, MD – ChairEzra Cohen, MD – Co-ChairDavey Smith, MD – Division Chief, Infectious Diseases & Global Public HealthAtul Malhotra, MD – Division of Pulmonary/Critical Care & Sleep MedicineSusan Little, MD – Division of Infectious Diseases & Global Public HealthKimberly McConnell, PharmD – Investigational Drug ServicesEric Mah – ACTRI (ex officio)SupportKarlyle Lim3Membership
4. To review all proposed clinical trials at UCSD Health that aim to enroll participants with diagnosed or suspected COVID-19 disease to determine appropriateness and feasibility for patient populations served by UCSD Health.4Charge
5. Is there appropriate scientific justification for studying the intervention in question?Is the study design appropriate to test the hypotheses stated?Is the study feasible to conduct within inpatient or outpatient settings at UC San Diego Health?Is the funding available adequate to conduct the study?Are there other competing studies already underway or pending at UC San Diego Health that will impact the ability to recruit the proposed sample size and/or impact the staffing available to conduct the study?Do UCSD investigators play a key role in the development and implementation of the clinical trial that would be important for research objectives of UCSD Health? 5General Criteria to Evaluate COVID-19/SARS-CoV-2 Clinical Trials for Implementation at UC San Diego Health
6. All clinical trials must be reviewed and approved by the Clinical Trial Committee before submission to the IRB. Principal Investigator will prepare Submission Packet outlining their proposed study and send to Dr. Benson & Karlyle LimA Primary Reviewer will be assigned from the CommitteeThe Covid-19 Clinical Trials Review Committee will convene on the 1st and 3rd Thursdays of the month to discuss submissionsReview Decision will be communicated back to PI6Process Overview
7. Approved: Protocol moves on to IRB for reviewApproved with Contingencies: Protocol may move on to IRB once contingencies are addressed, e.g. plan for coordination of enrollment with other ongoing trialsDeferred: Review Committee may require further explanation, information or input about specific areas of the protocol study and implementation plans identified during the review. In this situation a decision is deferred until the Review Committee receives the requisite information.Disapproved: Protocol cannot be implemented at UC San Diego HealthInvestigators have the option to appeal; requests for appeal and the basis for the appeal should be forwarded to Dr. Benson and Karlyle Lim.7Review Decisions
8. 8Process Map
9. Link to fillable PDF: Submission Packet for Investigators1-2 page Study SchemaIncludes study design, interventions, brief rationale, primary and major secondary objectives, sample size, duration, inclusion and exclusion criteria, and brief paragraph summarizing statistical analytical considerationsLatest version of the full protocolInvestigator’s brochure, if availablePharmacy Manual of Operations or Handling Guide, if available9Materials to be Submitted by Investigator/PI
10. Investigator’s Assessment checklist with description of the following:Investigator’s role - was the study a UCSD or UCSD investigator initiated proposal or of unique importance to UCSD?Sponsor and funding sources (attach proposed budget, if available)UCSD resources required and if available (yes/no):Nursing/study coordinator supportInvestigational pharmacy servicesLaboratory support for specimen collection, processing, storage, shipment, specialized testingCase report forms, data entry/data management, IT supportFiscal support (invoicing, budget preparation and monitoring, Velos and coverage analyses)Study supplies (PPE, lab, data management, etc.) 10Materials to be Submitted by Investigator/PI (cont’d)
11. UC San Diego HealthDr. Constance Benson | cbenson@health.ucsd.eduKarlyle Lim | kclim@health.ucsd.edu