Review Services
Grant Application Checklist
Advarra offers unparalleled expertise in single institutional review board (sIRB) preparedness and review, ensuring streamlined study activities, consistent participant protections, and optimized compliance. As the research community’s preferred sIRB partner, we help you meet regulatory requirements with efficiency and transparency.
Institutional Review Board (IRB)
- Does your funding source require sIRB oversight?
- If sIRB oversight is required, is your local IRB able to provide this? Or do you need to look outside the institution?
- Most federally funded studies involving multiple sites, including collaborative research studies,
must now use a sIRB for all sites. - Some institutional IRBs do not have the operational resources to support multisite studies, or do not
have the capacity to provide fast turnaround times to support your study’s goals.
- Most federally funded studies involving multiple sites, including collaborative research studies,
Data Monitoring Committee (DMC) / Data Safety Monitoring Board (DSMB)
- If any of the following are true for your study, you may need to include a DMC in your plans:
- The study endpoint is such that a highly favorable or unfavorable result (or finding a futility at interim
analysis) might ethically require study termination before its planned completion. - There are reasons for a particular safety concern (e.g., if the procedure for treatment administration is
particularly invasive). - There is prior information about the study treatment suggesting the possibility of serious toxicity.
- The study is performed in a potentially fragile population, such as children, pregnant women, the
very elderly, people who are terminally ill, people of diminished mental capacity, or other vulnerable
populations. - The study is performed in a population at elevated risk of death or other serious outcomes (even when the study objective addresses a lesser endpoint).
- The study is large, of long duration, blinded, or multi-center/multi-national and would benefit from additional oversight.
- The study endpoint is such that a highly favorable or unfavorable result (or finding a futility at interim
- Does your institution have capacity to support a DMC for the duration of the trial?
- Will you have access to the expertise necessary for this particular study?
- Will that DMC be appropriately independent from study conduct? Per Food and Drug Administration (FDA) and EU European Medicines Agency (EMA) guidelines, independence is a critical element.
Institutional Biosafety Committee (IBC)
- NIH Guidelines require IBC oversight if the following apply:
- The research involves the use of recombinant DNA (rDNA), including messenger RNA (mRNA), synthetic nucleic acid (sNA) molecules, or other genetically engineered treatments, AND
- Either the site or the sponsor has received National Institutes of Health (NIH) support for rDNA or sNA research in the past, or is currently conducting NIH-supported studies involving rDNA or sNA.
- This includes sites and sponsors outside of the United States.
- Even if there is no NIH support involved, IBC review is a best practice per NIH Guidelines Section IV-D-1.
- Does your institution have a local IBC to provide clinical trial oversight?
- Many local IBCs focus primarily on preclinical and nonclinical research.
- Advarra coordinates IRB and IBC review to streamline startup processes
Endpoint Adjudication Committee (EAC) / Clinical Event Committee (CEC)
- Your study may require an EAC if:
- Trial endpoints are complex, and some degree of medical judgment is needed to determine if a
participant has met a protocol-defined endpoint. - Specific therapeutic expertise is needed beyond that of the principal investigator or sponsor’s medical
monitor.
- Trial endpoints are complex, and some degree of medical judgment is needed to determine if a
- Does your institution have capacity to support an EAC for the duration of the trial?
- Will you have access to the expertise necessary for this particular study?
- Will that EAC be appropriately independent from study contact? Per FDA and EU EMA guidelines,
independence is a critical element.
Protocol Development and Informed Consent Form (ICF) Writing Services
- Who will develop the protocol and ICF for the trial?
- Do your internal resources have sufficient time to commit to providing this support?
- Do your internal resources have the appropriate skills and knowledge to prepare a protocol and
consent that will help achieve study goals and meet local and federal regulatory requirements? - Developing these documents requires specialized knowledge – not only of the trial itself but also of
the applicable regulatory requirements. It also requires dedicated time to write a protocol and ICF,
sometimes weeks or more.
- Do you have access to template tools that might inform development of these documents?
- Note: not all studies will easily “fit” into existing standard templates.
Research Staffing
- Have you already secured commitments for the dedicated roles your study will require?
- Bear in mind: Your local staffing situation may be different by the time your study requires support
from these roles. - It may be prudent to future-proof your trial by requesting funds to staff certain key roles including: clinical research coordinators, regulatory coordinators, director of clinical operations, clinical research nurse, project managers, data specialists, or study activation coordinators.