Va Submission Checklist

VA ECHCS SUBMISSION CHECKLIST

Prior to submitting your research protocol to COMIRB, please e-mail the following forms (if applicable) to the VA Research Office for pre-review. Forms can be obtained at: http://ucdenver.edu/academics/research/AboutUs/comirb/Pages/comirb-home.aspx

COMIRB FORMS: _____ COMIRB Application for Protocol Review Including attachments:______Request for Waiver of HIPAA Authorization (Attachment O) _____ Request for Waiver of Consent (Attachment M) _____ L1 COMIRB Attachment re: Decisionally-Challenged Patients at the VA _____ S1 COMIRB Attachment re: Storage &/or Banking of Human Biological Specimens _____ HIPAA VA Authorization A1: Research Recruitment _____ HIPAA VA Authorization B: Enrollment into Research _____ Protocol _____VA Consent Form (with VA standard statements) _____ Questionnaires, diaries, surveys, advertisements, flyers _____ Statement of Investigator (FDA 1572) _____ FDA letter noting the following but not limited to: IND or IDE #, _____Sponsor, IND/IDE name, Date of submission, Date of Receipt _____ Investigational Brochure

VA-SPECIFIC FORMS (DO NOT SUBMIT TO COMIRB) _____ Protocol Submission Packet Title Page & Billing Information _____ VA Investigator Agreement PLEASE SUBMIT W/VA PI SIGNATURE _____ VA ECHCS Recruitment Checklist _____ Principal Investigator C.V. (please sign/date first page) _____ SRS (Subcommittee for Research Safety) _____ RPSS (Research Protocol Safety Survey) Form PLEASE SUBMIT AS A ‘WORD’ DOCUMENT; SUBMISSION OF A SIGNATURE PAGE IS REQUIRED FOR SRS PROCESSING. SIGNATURE PAGE SIGNED BY VA PI CAN BE AN ELECTRONIC SIGNATURE OR ‘PDF’ FORMAT OR FAX TO 303.377.5686 _____ SRS Update Form – same as above _____ Authorization to Transport…Utilize VA Sensitive Information PLEASE SUBMIT W/VA PI SIG _____ Data Privacy and Security Plan Checklist PLEASE SUBMIT W/VA PI SIGNATURE _____ Research Impact Statement (with all appropriate signatures – please see RIS for details) ___Laboratory Service (if applicable, submit Lab Testing Form and Pathology and Lab Service Approval Form w/VA PI signature) ___Imaging Service ___Pharmacy Service (if any drugs are involved, submit Investigational Drug Information Record- Form 10-9012) Email to [email protected] ___Nursing Service (if applicable, submit Nursing Service Contract Approval w/VA PI signature) ___Other Services (if applicable, e.g. Union representative if VA employees are subjects)

PLEASE ROUTE RIS AT THE SAME TIME AS SUBMISSION TO VA RESEARCH OFFICE FOR PRE-REVIEW. THESE SIGNATURES ARE NOT REQUIRED BEFORE SUBMISSION TO COMIRB …..BUT MUST BE OBTAINED BEFORE PROTOCOL IS PLACED ON R&D MEETING AGENDA.

Please email your packet to Connie Steinbrunn at [email protected]. After submission of your packet to the VA Research Office, it will be pre-reviewed for VA guidelines, as well as possible changes. The VA Clearance Letter will then be faxed to the coordinator/primary contact. You must include this 2-page Clearance Letter with your submission to COMIRB. Revised 1/10/13