Institutional Review Board (IRB) Office of Regulatory & Research Compliance (ORRC) University at Albany, MSC 309 (Phone) 518-437-3850 (Fax) 518-437-3855 (E-mail) irb@albany.edu Date Received ORRC Assigned : JG ___ TR ___ AB___ Date: _______________ Submission # Date of determination: ________________ 11.01.13 Submit, via mail or hand delivery, one complete, signed protocol package with all attachments. IRB PROTOCOL CLOSURE FORM (DO NOT LEAVE ANY QUESTIONS BLANK, INDICATE N/A WHEN NECESSARY) Principal Investigator(s): Protocol Number: Protocol Title: Protocol Expiration Date: E-mail (must be UAlbany domain email address) : Campus Address : DO NOT LEAVE ANY QUESTIONS BLANK, INDICATE N/A WHEN NECESSARY 1. Protocol Status (Check One): Work Completed This is the final report, protocol can be closed. NOTE: ALL 4 BOXES BELOW MUST BE CHECKED TO CLOSE PROTOCOL. All subject recruitment and enrollment is complete (i.e., no new subject recruitment or enrollment are ongoing) All subject specimens, records, data have been obtained (i.e., no further collection of data/information from or about living individuals will be obtained) No further contact with subjects is necessary (i.e., all interactions or interventions are complete and no further contact with enrolled subjects is necessary) Analysis of subject identifiable data, records, specimens are complete (i.e., use or access to subject identifiable is no longer necessary. Note: this includes review of source documents by study sponsors.) Study Cancelled Work on Protocol was never initiated, and will not be done/Data has not been collected. Other Explain: 1 2. Study population summary. Please answer the following questions for research activities covering the past 12 months: The number of participants enrolled: The number of participants who withdrew or discontinued participation in the research to date: The number of participants who completed the study: Have any participants become incarcerated? Yes No If yes, include number A summary of any adverse events and unanticipated problems involving risks to participants or others: (Criteria for reporting of adverse events can be found at our website –Link- “Adverse Event Report Form”) A summary of the reasons for participant withdrawal and any complaints about the research since the last IRB review: 3. Provide a brief summary of the research findings: 4. Provide a summary of the intended disposition of all research data, records and findings: 5. Other: PRINCIPAL INVESTIGATOR ASSURANCE - By signing this form you are acknowledging the following: You certify that all submitted statements about this research study are true and accurate. If you are a student principal investigator, you are responsible for obtaining review and approval of this form from your faculty advisor. Print Principal Investigator Name Principal Investigator Signature Date FACULTY ADVISOR ASSURANCE (if applicable; required when PI is a student) - By signing this form you are acknowledging the following: You have reviewed and approved the information reported on this form. Print Faculty Advisor Name Faculty Advisor Signature 2 Date