The Durham is the lead site The Durham PI is the lead investigator or study chair. for all sites. The Durham VA PI is the local site investigator. Duke is the only other site This is a non-VA sponsored multi-site study. The DVAHCS is the coordinating center Other: 2. If the DVAHCS is the coordinating center or lead site, the following must be assured by the DVAHCS Principal Investigator: N/A I understand that the DVAHCS IRB must determine if other sites are engaged in research. If they are engaged, then that site’s IRB must approve the study. I will provide copies of IRB approvals from other sites determined to be engaged in research as they are available. I will ensure that the study is not initiated at other sites prior to approval or exemption by their IRB. 4. A local site-specific protocol or the Durham VAHCS Local Protocol Addendum is included: YES NO Note: A local site protocol or Durham VAHCS Local Protocol Addendum is required for multisite studies that use a centralized protocol or for multisite trials for which DVAHCS is not the lead site. L. Study Staff 1. This study will include Co-investigators at the DVAHCS? If yes, Submit a Conflict of Interest form for each DVAHCS investigator YES NO 2. Each research staff member has an appropriate Research Scope of Practice on file, or appropriate Research Scope of Practice documents are included with this application. YES NO 3. Does the involve initial clinical evaluation or ongoing clinical monitoring during the study? YES NO If yes, check all that apply: Study staff or participant’s health care provider will be responsible for the initial clinical evaluation. Study staff or participant’s health care provider will be responsible for monitoring clinical status. All study staff who will provide clinical procedures or monitoring as part of this study are trained and qualified with appropriate credentials and privileges within DVAHCS. M. Research Data Information 1. Indicate the type of data will be obtained and recorded study team? Check all that apply: De-identified Data does not contain any identifiers that could link the data to a specific – participant. Identifiable– Data contains direct identifiers, including the 18 HIPAA identifiers, sufficient to identify participants. A unique code will be assigned to a set of otherwise de-identified health information to Coded – permit re-identification. The code will not be derived from or related to information about the
The Durham is the lead site The Durham PI is the lead investigator or study chair. for all sites. The Durham VA PI is the local site investigator. Duke is the only other site This is a non-VA sponsored multi-site study. The DVAHCS is the coordinating center Other: 2. If the DVAHCS is the coordinating center or lead site, the following must be assured by the DVAHCS Principal Investigator: N/A I understand that the DVAHCS IRB must determine if other sites are engaged in research. If they are engaged, then that site’s IRB must approve the study. I will provide copies of IRB approvals from other sites determined to be engaged in research as they are available. I will ensure that the study is not initiated at other sites prior to approval or exemption by their IRB. 4. A local site-specific protocol or the Durham VAHCS Local Protocol Addendum is included: YES NO Note: A local site protocol or Durham VAHCS Local Protocol Addendum is required for multisite studies that use a centralized protocol or for multisite trials for which DVAHCS is not the lead site. L. Study Staff 1. This study will include Co-investigators at the DVAHCS? If yes, Submit a Conflict of Interest form for each DVAHCS investigator YES NO 2. Each research staff member has an appropriate Research Scope of Practice on file, or appropriate Research Scope of Practice documents are included with this application. YES NO 3. Does the involve initial clinical evaluation or ongoing clinical monitoring during the study? YES NO If yes, check all that apply: Study staff or participant’s health care provider will be responsible for the initial clinical evaluation. Study staff or participant’s health care provider will be responsible for monitoring clinical status. All study staff who will provide clinical procedures or monitoring as part of this study are trained and qualified with appropriate credentials and privileges within DVAHCS. M. Research Data Information 1. Indicate the type of data will be obtained and recorded study team? Check all that apply: De-identified – Data does not contain any identifiers that could link the data to a specific participant. Identifiable– Data contains direct identifiers, including the 18 HIPAA identifiers, sufficient to identify participants. Coded – A unique code will be assigned to a set of otherwise de-identified health information to permit re-identification. The code will not be derived from or related to information about the
Initial_Review_nonexempt_12_03_18.docx