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Roadmap to Quorum's New HandbookAs part of the Quorum Study Advantage, Quorum has developed a handbook that provides critical guidance in working with Quorum Review. The Handbook provides assistance for sponsors, contract research organizations and researchers on issues ranging from study start-up to study closing. We believe that the information in the Handbook will facilitate a smooth study startup and also help researchers comply with their obligations to the IRB. The Quorum Handbook can be found on Quorum's website. The Handbook is a comprehensive guide to Quorum's policies and procedures. The topics addressed in the Handbook include the following. Study Start-Up Guidelines. For sponsors, the Handbook summarizes the documents that must be submitted in order to initiate a central study, a single-site study or a PI-generated study. The Handbook also outlines the issues that the IRB expects a protocol to address. For sites, the Handbook summarizes the documents to needed for study start-up. A list of "helpful hints" is included to help investigators avoid common mistakes in submitting documents. The Handbook also includes Quorum's guidelines on completing the Site Information Questionnaire ("SIQ"). Recruitment Materials. The FDA requires an IRB to review an investigator's study recruitment materials. With that said, it is not always clear what documents should be submitted to the IRB for review. The Handbook describes Quorum's policies regarding:
Informed Consent. Over the years, Quorum has developed policies pertaining to how the consent form should address a number of issues, including compensation, state-law issues, confidentiality and readability. The Handbook summarizes these policies. The Handbook also outlines the logistics of how a model consent form is developed in collaboration with the sponsor as well as the steps a site should take in order to obtain a unique, site-specific consent form. The Handbook also addresses the informed consent process. Sites often must deal with difficult issues in obtaining informed consent, and the Handbook addresses special topics such as obtaining the assent of minors, obtaining consent from legally authorized representatives ("LARs"), and the issues raised by mentally incapacitated adults, illiterate adults and individuals who don't speak English as a primary language. HIPAA and HIPAA Waivers. The Handbook describes Quorum's general policies regarding HIPAA and Quorum's position that the consent form should meet HIPAA's standards. From time to time Quorum's researchers seek partial HIPAA waivers for recruitment purposes or full waivers for certain types of studies. The Handbook outlines the issues raised by such waivers under both state and federal law. Emergency Test Use of Article. Even though Quorum does not review planned emergency research, it is possible that one of Quorum's investigators will seek to use a test article on an emergency basis. The Handbook outlines how an investigator in such a situation should request permission from the IRB for such use. Expectations of Sponsors and Researchers. Federal regulations impose a number of obligations on sponsors and researchers. The Handbook outlines Quorum's expectations of researchers and investigators from an IRB's perspective. The Handbook also describes specific policies for investigators, such as a policy requiring the disclosure of conflicts of interest. Changes in Research Activity. The Handbook reminds researchers that Sponsors and investigators are responsible for obtaining prospective IRB review for changes in research activity. The Handbook then describes the logistics for submitting changes in all types of research activities, including protocol amendments, consent form modifications and changes in the investigator's facility. Prompt Reporting of Unanticipated Problems and Safety Information. Quorum requires certain events to be reported promptly to Quorum (within ten business days of discovery by the researcher). The Handbook outlines which events should be promptly reported, such as significant adverse events ("SAEs"), major protocol deviations and other unanticipated problems that involve risk to the participant or others. Continuing Review. Quorum expects both sponsors and sites to submit continuing review reports at the time of a study's continuing review. The Handbook describes the policies and procedures for continuing review. Site Closure. The Handbook spells out the criteria by which a site can determine whether it should submit a closing report to the IRB. We are excited to roll out this important tool for supporting the work we do with sites, CROs and sponsors. The Quorum Handbook is a password-protected document located on Quorum's website. Please contact Quorum's Site Support Team or Customer Relations Department for password access. |
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