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Employees Site |
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URGENT NEW ANNOUNCEMENTS !!!! |
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RESEARCH OUTREACH PROGRAM Dear Human Research Investigators and Study Staff: Please remember to obtain and maintain a supply of the VA brochure: “Volunteering in Research – Here are some things you need to know” · Make them available in your workplace ‘traffic’ area · Distribute them to prospective research subjects. · The brochure must be given to every prospective participant, when the individual is approached to take part in a project. (All consented subjects) Brochures are available from the IRB Coordinator, extension 3879 This is part of the VA research outreach program that began February 28, 2009 (VHA Dir 2008-079). ~~~~~~~~~~~ posted 7/12/09 |
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Electronic Computer Access Request: ECAR
Use the web based ECAR program to request authorization to transport/utilize sensitive information outside VANJHCS protected environment and to request for IRM provided equipment. Here is the ECAR web site address: https://ecar.v03.med.va.gov/do/main/logon A user guide is available on the ECAR website. A link to the ECAR website is also available on the forms page in the SECURITY section of this VBRI website. January 26, 2009 |
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Guidance for Organization of Human Research Regulatory Records Guidance for maintaining study records is available on this VBRI website. The guidance is on the Procedures page. [See: Guidance for Organization of Human Research Regulatory Records] Not all the sections are applicable to all studies. Sample forms and explanations are provided. The forms are intended to serve as examples that may be adapted for your use. The contents include: ESSENTIAL DOCUMENTSProtocol & Amendments Operations Manual - Approved Case Report Forms IRB Approved Consent Forms / Information Provided to Subjects Subject Log / Clinic Lists in CPRS IRB Submissions / Notifications / Approvals Serious Adverse Events / Safety Reports Notes-to-File Investigator Agreements (with Sponsor, Institution, FDA, etc.) Study Site Personnel (Signatures, Qualifications, Training) Site-Sponsor Correspondence - Conference call minutes (section tab provided) - Newsletters (section tab provided) Investigator Brochure (DIR) / VA Form 10-9012 Investigational Products (Accountability, Handling, Pharmacy) Laboratory Subject Files Visitor Log (Site Visitor Log would be a more accurate term for this form)
More information: Forms and Tools may be obtained from the SMART Website https://vaww.csp.research.med.va.gov/smart.cfm Posted Dec 5th,2008 |
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Announcing New Financial
Disclosure Form Dear Investigators:
The financial disclosure form has been revised with content approved by General Counsel and consistent with requirements for CRADAs. The new form (7/11/08 version) will be required for submissions for the 8/18/08 IRB meeting. The submission deadline for that meeting is 8/1/08. The form may be obtained through the VANJHCS Research website (on the VBRI website). Thanks,. Orval Gautier, M.Ed., CIP, Research Compliance Officer |
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YOUR PROTOCOL HISTORIES AVAILABLE FOR SELF EVALUATION OF STUDY RECORDS Dear Human Research Investigators and Study Staff: One of the primary references used in the local Research Compliance review of investigators’ records is the “Protocol History”. All of the submissions to the IRB and approvals are listed and each of the items must be part of the investigator’s study records. The R&D Committee suggested that the Protocol Histories be made available to investigators so that in advance of any audits you can check to confirm that all the listed items are present in your study files. You are encouraged to request a copy of the protocol history for each of your studies through me or directly from the IRB Intake Staff Person: Ms. Cheryl Dillard at extension 1794. It can be provided in hard copy or as a pdf file e-mail attachment. The Protocol History does not reflect all the documents to be maintained in study files. The data collection tool lists other items that are part of the review: Investigator’s Human Research Records: Accountability and Safe Guard Checklist Oversight agencies such as the VHA Office of Research Oversight (ORO), VHA Office of the Inspector General (OIG), the DHHS Office for Human Research Protection (OHRP) and the FDA may conduct inspections and investigations that could involve review of your study records. You need to be able to demonstrate that you are maintaining adequate study files and readily produce required documents during a regulatory site visit. It is suggested that you obtain protocol histories and establish a process for review of your own study records (with correction and reorganization as necessary). posted 3/20/2008 |
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Questions, Concerns and Suggestions are Welcome from Investigators and Members of the Research Community regarding the Human Research Protection Program and other Research issues The following individuals are available to respond to your research Questions, Concerns and Suggestions:
ACOS/ R&D: Richard P. Wedeen MD x 7877 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
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Privacy Training (click on link) PHI Disclosure Reporting (see forms page)
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Office Staff:
Research Office Telephone (973) 676-1000, ext. 3880, 1269; Fax: 973 395 7184
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