Coordinating Center Regularstudy Application Research Summary Template

Coordinating Center RegularStudy Application Research Summary Template

DO NOT SUBMIT THIS INSTRUCTION PAGE

When is it appropriate to use this research summary template?

This research summary template is for eIRB submission of a multi-site clinical research protocol, regular study application in which Duke is engaged in research and serves as a coordinating center (e.g., central clinical coordinating center, statistical coordinating center) or provides a central resource (e.g., Data Coordinating Center, Health Economics and Quality of Life (EQOL) coordinating center, Clinical Events Committee, Central Imaging, etc.) for the study because:

A Duke investigator receives identifiable private information (such as name, subject initials, date of birth) about the subjects of the research that would enable Duke study staff to readily identify the subjects of the research; or
A Duke investigator has direct interaction/intervention with human subjects; or
A Duke investigator is the direct recipient of a grant, contract, or cooperative agreement from the US federal government for human subjects’ research funding the protocol under review, whether research activities occur at Duke or elsewhere; or
A Duke investigator is the sponsor of the protocol under review (i.e. this is a Duke PI-initiated study); or
The study involves and IND or IDE under which regulatory reporting to the FDA would be required for the protocol under review.

NOTE:If your project is not a multi-site coordinating center protocol, this user guide is not applicable to you.

NOTE: If your research is not a multi-site coordinating center protocol, and you are not the coordinating center or central resource for the study this research summary is not applicable to you.

The Research Summary should include sufficient information for evaluation of the proposed research. The PI is expected to provide any additional information requested for review by the IRB.

Use of the template research summary below will insure that certain minimum essential information related to the implementation of the protocol at Duke has been provided to the IRB. The information submitted to the IRB should describe what occurs at Duke in sufficient detail for the IRB to determine that regulatory and institutional requirements have been met.

Using the bolded headings in the research summary template will aid reviewers’ understanding of the Department/Institute/CRU responsibilities you are describing in your application. Include research summary version date and page numbers on each page of the summary (e.g., in the document’s footer).Text in italics is an instruction; text in a plain font can be copied and used verbatim.

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Coordinating Center RegularStudy Application Research Summary Template

Protocol title – insert the protocol title.
Does this study involve an IND or IDE?
Your Department/Institute/CRU role/responsibilities in the study:

In this part describe your role in the study (e.g., Coordinating and/or Statistical Center or Outcomes) and your responsibilities in the study(i.e., project management, data management, site coordination/site monitoring, study design, project development and/or implementation, etc.). Provide a detailed description of what is involved in each of these activities.

If there are research partners that are identified in the protocol or elsewhere (or if your Department/Institute/CRU has subcontracted research activities to research partners), list those research partners here ad briefly explain their responsibilities.

NOTE FOR DCRI STUDIES ONLY: If this is a DCRI submission, and there are multiple DCRI functional groups involved in the study, e.g. Clinical Operations, Outcomes, CEC, Imaging, etc., list each group and their responsibilities in the study.

For federally funded studies, include the following additional information about your federal funding:

Are the funds received by Duke sent to one or more intervention/other sites to support:
Research activities related to a Coordinating Center, Statistical Center, Central Laboratory, or Reading Laboratory or other similar facility at Duke ONLY?
Research activities involving human subjects at Duke and one or more other institutions?

If federal (NIH, FDA, DoD, etc.), provide information about whether this study application PI is the primary awardee of the contract/grant/cooperative agreement. If so, provide a copy of the entire funding document including any statements of work.

Describe whether or not funds from the federal government sent to Duke will be further distributed to the intervention sites for the research. State whether or not the funds disbursed by Duke will be paying for interventions that are greater than minimal risk either at the intervention sites or under the coordinating center protocol.

If DoD funded, and the faculty listed as PI on this application is the primary awardee, provide information about the independent medical monitor and a description of the scientific review process conducted priorto IRB review of the protocol (by whom was it conducted, what specific scientific aspects were reviewed and any comments from the reviewer)

FOR DCRI studies only:DUHS IRB and DCRI have agreed on a process for listing key personnel on an IRB application. DCRI is following the training SOP that’s now on file with the IRB (Pro00040507). Nevertheless, the protocol submission to the IRB must list certain key individuals under Key Personnel, including but not limited to the PI, the Project Leader, the Regulatory Coordinator, the Clinical Research Coordinator, and any co-PIs as applicable.

Purpose of the study – [objectives & hypotheses to be tested, brief description]
Background & significance – [should support the scientific aims of the research, brief description]
Design & procedures – [A brief description of the research that includes the objectives and conduct of the study procedures]

The subject population (include number of subjects, age range), or the materials (records or specimens and their source) to be used in this study.In addition, give the following specific information about your project:

a)Do you obtain informed consent of human subjects for research?

b)Is your Department/Institute/CRU responsible for developing the template consent form for subjects at the intervention sites? If so, provide a copy for review. Should be attached in Section 7 of the IRB application.

c)Is your Department/Institute/CRU responsible for ensuring that all sites have IRB/Ethics board review/approval and, when applicable, FWAs? If so, provide a copy of the approvals when available or, if greater than 10 sites, the location where they are stored and whom to contact if the IRB, CTQA or other HRPP office requests access to them.

d)Is your Department/Institute/CRU responsible for any audit functions of sites conducting the research? If so, please describe the process, frequency, where the audit records are stored and whom to contact if the IRB, CTQA or other HRPP component requests access to them.

e)Does your project involve an interaction/intervention with a living individual for research purposes?

f)For this study, what subject information will be collected and from where?

g)What subject-specific information will be collected/received by your Department/Institute/CRU along with the research data/health information: for example, are you collecting/receiving any subject identifiers such as birth date, procedure dates, initials, ZIP code, etc.? Are you collecting/receiving clinical or research data from the subjects? Are you collecting/receiving information from medical records?

h)If your Department/Institute/CRU receives any subject identifiers, direct or indirect, such as birth date, initials, procedure dates or ZIP code, include information about the following:

Can your study team members readily identify any subjects using the information?
Will your study team members obtain or seek to obtain the key to the code that could be used to identify subjects?
If your study team members inadvertently receive information from a site that can identify a research subject, describe whether or not the information will be accepted. (When applicable, your study team will work with sites to ensure they send only information and identifiers that have been requested)
If receipt of subject information by your Department/Institute/CRU is not specifically described in the consent/authorization form for the study, provide a request for a waiver of consent/authorization for receipt of that information. This waiver should be attached in section 7 of the IRB application.
If the subject information is from DUHS patients and any of the study team members for the coordinating center have access to direct subject identifiers (for example, if they are on the study team for the intervention site at Duke), provide a description of how those study team members will be unable to readily identify the subjects from the data they will use/have access to, in the coordinating center protocol (if applicable) or the purpose of those study team members retaining access to the identifiable information.

i)For a project using coded subject information or samples, were the data or samples obtained specifically for this research project?

j)Does your project involve the use of coded data or specimens linked to identifiable private information, such as a subject’s name or Social Security number with a key/code? If so, who keeps and has access to the key/code?

k)Does your project involve the use of coded data or specimens that are linked to a code in such a way that the subject is readily identifiable to your research team based on the code? If so, was consent/authorization specifically obtained for your Department/Institute/CRU to receive that information?

l)Does your project involve use of anonymized data/specimens (no key/link has been kept between the coded data and direct subject identifiers)?

m)For a project using coded private information, is a written agreement in place prohibiting the release of the key to the research team under any circumstances?

Selection of Subjects – If applicable, copy the following into this section:We do not have any role in selection of the research subjects: this is the responsibility of the enrolling sites.
Subject recruitment and compensation – If applicable, copy the following into this section:We do not have a role in recruiting or compensating research subjects: this is the responsibility of the enrolling sites.
Consent process–If applicable, copy the following into this section: We do not have any role in consenting subjects: this is the responsibility of the enrolling sites.
Subject’s capacity to give legally effective consent –If applicable, copy the following into this section: We do not have any role in assessing subjects’ capacity to give legally informed consent: this is the responsibility of the enrolling sites.
Risk/benefit assessmentof study in general– [check protocol and list possible risks/benefits]
Risk/benefit assessmentof your Department/Institute/CRU Study Activities and/or Interventions– [list possible risks/benefits and how risks are minimized.]
Costs to the subject, and compensation –If applicable, copy the following into this section: We do not have a role in compensating research subjects: this is the responsibility of the enrolling sites.
Data Analysis & Statistical Considerations – [If this is part of your Department/Institute/CRU Activities/responsibilities provide a description of what is done specifically by the study team at Duke (local information, not cut/paste of multi-site protocol); if not, excerpt summary from protocol].
Data & Safety monitoring – [Excerpt information from the study protocol to summarize safety concerns, and describe the methods to monitor research subjects and their data to ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a data monitoring committee will be used, describe its operation, including stopping rules and frequency of review, and if it is independent of the sponsor (per 45CFR 46.111(a) (6)). If applicable, provide a description of what is done specifically by the study team at Duke (local information, not cut/paste of multi-site protocol) as it relates to your Study Activities and/or Interventions.]
Privacy, Data Storage & Confidentiality – See section 12 of eIRB.

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