Tag: ai

Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

Co-Author: Tasha Mohseni

Co-Author: Yefrenia Henriquez Taveras

Good morning, good afternoon, good evening Compliance Rockstars, Clinical Researchers, Ethics Educators, and Investigators from around the world!

We are so excited about sharing the second Show-and-Tell post within a highly educational series!

Before we get started, we wanted to share an important announcement:

This series was originally going to be 12 posts (i.e., a post per month).

However, due to the incredible feedback we received, we will no longer follow this format.

The series will conclude once all aspects of an IRB submission are covered! This may be a post per month (or multiple posts per month).

Your feedback is much appreciated, and we look forward to producing and providing this helpful content!

Before we give into this post:

We want to tell you about our methodology of assessing 16 biomedical IRB protocol templates from various institutions.

Being in the compliance field, we are also passionate about research. More importantly, passionate about doing research ethically and in a reproducible way. We are going to summarize how we analyzed 16 biomedical IRB protocol templates from various institutions for commonalities:

1. We went to Google and typed in “IRB Templates”.
   • From here, we only reviewed templates with the following keywords:
     • “Biomedical”
     • “Bioscience”
     • “Medical”
2. Our initial plan (similar to the past post) was to stop once we browsed through 10 pages. Which we did and were hoping to have 50 records for review.
   • But…we encountered obstacles:
     • Some institutions had templates for consent and recruitment, but not for the protocol (perhaps this is an internal document in the electronic IRB submission system)
     • Some institutions relied on Federal agency templates (which is completely fine, but I said I would do my search on institutions)
     • Some institutions only had one type of protocol template (i.e., no difference between SBER or biomedical research) – again this is completely fine depending on the nature of the research at your institution
     • Some institutions required an institutional login to access their templates (hear, hear for additional security!)
     • Some institutions had protocol templates based on review type (exempt, expedited, vs. full board) – this is interesting to me because I wonder how these institutions have trained their investigators to know which template to use
     • Some institutions may have had biomedical protocol templates, but we were limited by the keywords we selected
3. After going through 10 pages of results, we decided to stop once we reviewed 16 institutions’ biomedical protocol templates.
   • We could have kept going, but we wanted to be consistent with the previous analysis we did in terms of the number of protocol templates reviewed
4. As we reviewed each template, we gathered the following data points:
   • A link to their PDF for future reference
   • Their institution only to avoid duplicate values (once we had 16 unique values – this column was deleted)
   • Sections within their protocol template
5. Then, with iterative prompting via ChatGPT-4, the GPT summarized the recurring themes within the protocol templates.
   • If you would like to review any of our references, please leave us a comment below.

Though we will have references throughout the post from the following agencies, it is recommended that you visit the Federal Guidance Repository to review these resources:

• Office of Human Research Protections (OHRP) guidance documents
• Secretary’s Advisory Committee on Human Research Protections (SACHRP) recommendations
• Food and Drug Administration (FDA) guidance documents

As a general reminder, you should consult with your institution’s IRB if you have any questions about the resources provided at the end of this post (or the recommendations within this post to ensure it is applicable to your institution). Additionally, check if your institution already provides specific templates that you can use:

Study Leadership and Resources Available

Title

This should hopefully be one of the easiest parts of your biomedical IRB protocol! The title of your protocol should give the IRB reviewer a sense of what your IRB protocol will be about.

Is there a grant associated with your study?

If so, I recommend reviewing sponsor requirements. Some sponsors may require that your protocol title must be the same title as your grant.

Principal Investigator (and Study Team)

The institution must know who is the lead investigator (i.e., the principal investigator (PI)) for the biomedical study. This is typically a faculty or staff member. If the research is student-led, then the student should check with their institution to see if they can be listed as the PI. Some institutions may be fine with this, but require a faculty member to be listed on the protocol as well. The protocol should also list all study team members associated with your study. Whether they are affiliated with your institution or an external collaborator, IRBs want to ensure that everyone has received the proper IRB/human subjects research training.

Institution Team Members

These are team members that are affiliated with your institution.

External Collaborators

These are team members that are not affiliated with your institution. If the collaborator is affiliated with an institution, they will need to reach out to their IRB. The collaborator’s IRB may require that the collaborator submit a study for review. Conversely, the collaborator’s IRB may not considered them engaged in research. You may not know this, but institutions have flexibility in how to apply the regulations.

Stay tuned for an upcoming post that will discuss the reliance process and the single IRBs!

Qualifications to Conduct Research

This section should establish the research team’s expertise and ability to conduct the study ethically and competently. The goal is to demonstrate that the research team is capable, experienced, and well-trained. This provides assurance to the IRB that participants will be protected and the study will be conducted ethically. It should include:

Principal Investigator (PI) and key personnel

• Name, title, institutional affiliation, and role in the study.
• Description of the PI’s research experience, particularly in the relevant area of study.
• Previous experience conducting similar research (e.g., prior clinical trials, publications, or funded projects).
• If applicable, any specific experience working with the study population (e.g., vulnerable populations, specific disease conditions).

Training and certifications

• Completion of human subjects research training (e.g., CITI Program or NIH ethics training).
• If the study involves medical interventions, confirmation of Good Clinical Practice (GCP) training.
• Any other relevant compliance training (e.g., HIPAA, conflict of interest, biosafety).

Study team expertise and responsibilities

• Description of co-investigators, study coordinators, research nurses, and other key personnel.
• Each person’s role in the study and how their background supports the research objectives.
• If specialized skills are required (e.g., phlebotomy, radiologic imaging, data analysis), documentation of relevant experience.

Resources Available

This section should detail the institutional and external resources available to ensure the study is feasible and well-supported.

• Institutional resources and support
  • Describe the access to labs, clinical facilities, regulatory offices, and any core research services.
  • Include confirmation of adequate resources, including funding, personnel, infrastructure, and data management support.
• Collaborations (if applicable)
  • Describe of external partners’ roles and expertise.
  • Document agreements such as:
    • Data Use Agreements (DUAs),
    • Memoranda of Understanding (MOUs), and
    • IRB reliance agreements (for multi-site research)

Study Background and Rationale

Background and Significance

This is also known as:

• The study rationale (i.e., purpose) for the proposed research
• The study aims and hypothesis

This is where you briefly introduce the purpose of your proposed study. If your research is funded, the study aims should be consistent with your grant. This is also where you would include your research question(s) and hypothesis. You should also provide a summary of research currently available (i.e., publications) to provide justification for the proposed study. I caution you here to avoid any technical terms or jargon. Remember, IRB reviewers aren’t as connected to your project as you are.

Therefore, this section should be written in a way that anyone can understand:

• The main idea of the proposed research
• Any published research that is related to the proposed research
• Any current studies that are related to the proposed research (i.e., the ID number of any active studies related to the proposed research)
  • This helps IRB reviewers when they are making a determination for your study with respect to risk (i.e., no greater than minimal risk or above minimal risk)

Objectives (Primary and Secondary)

This section defines the specific goals of the study and differentiates between primary and secondary objectives.

• Primary objective
  • This is the main goal of the study and is typically the primary outcome the research is designed to evaluate.
  • Example: To assess the efficacy of [intervention] in reducing [condition-specific outcome] over [time frame].
• Secondary objective(s)
  • These are additional research questions that may provide supporting data or insights beyond the primary objective.
  • Example: To determine the effect of [intervention] on secondary markers such as [biomarkers, patient-reported outcomes, or other clinical indicators].
• Exploratory Objectives (if applicable):
  • These are hypotheses that may not be powered for statistical significance but can inform future research.
  • Example: To explore the relationship between [genetic marker] and treatment response.

Objectives should be expressed as statements of purpose (e.g., to assess, to determine, to compare, to evaluate). Each objective should correspond to specific endpoints and hypotheses tested in the study.

Study Design and Methodology

Study Design and Endpoints (Safety and Efficacy)

This section describes the study framework, endpoints, and how safety and efficacy will be assessed.

Study design

• Type of study: Clearly state whether it is an observational, interventional (clinical trial), randomized controlled trial (RCT), cohort study, etc.
• Study population: Define the target population, inclusion/exclusion criteria, and recruitment strategy.
• Study timeline: Outline key study phases, including screening, intervention, follow-up, and data analysis.

Study endpoints (safety and efficacy)

Endpoints are the measurable outcomes used to assess whether the study objectives are met. They should be directly linked to the study’s hypotheses.

• Primary endpoint:
  • The main measurement used to evaluate the primary objective.
  • Example: Reduction in [disease severity score] at [specific time point].
• Secondary endpoints:
  • Additional outcomes that support the primary objective or assess other aspects of intervention effectiveness.
  • Example: Change in quality-of-life scores, biomarker levels, or patient adherence rates.
• Safety endpoints:
  • Measures related to adverse events (AEs), serious adverse events (SAEs), laboratory test abnormalities, or other safety concerns.
  • Example: Frequency and severity of treatment-emergent adverse events.
• Efficacy endpoints:
  • Clinical or laboratory-based measures that assess how well the intervention works.
  • Example: Percentage of patients achieving remission or symptom reduction.

Evaluation of safety and efficacy

• Describe how safety and efficacy will be monitored, including data collection at study visits.
• Specify when primary and secondary endpoints will be measured (e.g., baseline, 6 months, 12 months).

Comparison of Usual Care and Study Procedures

This section should clearly outline the differences between standard clinical care and the study-specific interventions or procedures. It helps the IRB assess whether the study introduces additional risks beyond routine medical care. If comparing an investigational intervention to standard care, explain why neither is considered superior at the time of study design.

Study Drug, Device, or Investigational Agents

This section describes the investigational product(s) used in the study and their regulatory status:

• Provide the name, formulation, mechanism of action, and route of administration (if applicable)
• If it is a device, describe its function, intended use, and classification (e.g., diagnostic, therapeutic)
• Indicate whether the drug or device has FDA approval or is used under an Investigational New Drug (IND) or Investigational Device Exemption (IDE)
• If approved for other indications, state how its use in this study differs from approved uses
• Provide preclinical or clinical evidence supporting its use.
• For device studies, detail how the device will be used, any required training, and safety precautions
• Specify how adverse events, side effects, and safety concerns will be recorded and reported
• Outline participant monitoring requirements (e.g., lab tests, imaging, physical exams)

Participant Population and Recruitment

Inclusion and Exclusion Criteria

As the section heading implies, this is where you would describe:

• Criteria that makes the individual eligible for the proposed study
• Criteria that makes the individual ineligible for the proposed study

Special Populations

If not obvious, you want to provide the scientific rationale for any exclusions of special populations. Special populations under The Common Rule (45 CFR 46) are:

• Subpart B — Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
• Subpart C — Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
• Subpart D — Additional Protections for Children Involved as Subjects in Research

There are other examples of special populations that aren’t covered in the regulations. An individual can be part of a special population if they can be considered vulnerable in the research:

• Individuals with impaired decision-making capacity
• Economically or educationally disadvantaged persons
• Socially disadvantaged
• Terminally ill or very sick
• Racial or ethnic minorities
• Institutionalized persons (e.g., persons in correctional facilities, nursing homes, or mental health facilities)
• Dual role relationships (the investigator could be a manager or professor to the employee and/or student participant)

What is “vulnerability” in a research setting?

Below is a summarized table of when vulnerability can occur in a research setting:

Number of Participants

In this section, you would indicate the number of anticipated participants you plan to enroll in your proposed study.

Recruitment Methods

Here, I like to take the “Five W’s” approach:

• Who are you recruiting?
• Why are you recruiting these potential participants?
• What materials will be used for recruitment?
• Where will potential participants be recruited?
• When will recruitment begin?

Let’s look at these components one piece at a time.

The first question should be a concise statement of your inclusion criteria. When IRB reviewers ask who you will be recruiting, they aren’t looking for specific names. They are looking for the population of interest that will help answer your research question(s).

The second question is aiming towards providing justification for the population of interest. How will this particular population help you answer your research question(s)? What is it about this population that would benefit from the proposed research?

For the third question, IRB reviewers are trying to understand what materials you will be using to recruit participants. Will potential participants be contacted via email? What about social media? Do you plan to do in-person recruitment where you will distribute fliers related to your study?

Typically, the fourth and fifth questions are a combined statement. Something to keep in mind is in-person recruitment. Say you are going to an event where you plan to distribute recruitment fliers for the proposed research. Do you have permission to distribute recruitment fliers for research purposes? You will want to make note of any site permissions you have obtained for the proposed research. The IRB reviewer will likely want to review the site permission documentation as well. Be sure to include any explicit permissions within your submission.

Screening Procedures

Describe the screening process of how you will confirm that potential participants meet inclusion/exclusion criteria. Further, describe what will happen to screening/eligibility data for individuals who are not eligible to participate.

Informed Consent

The consent process should outline key information from the investigator that should be provided to participants. The key information here should facilitate the participant’s comprehension and voluntariness of potential participation in your study. Though there are standard required elements of consent (and additional requirements depending on your study), at minimum, your consent form should include:

• The study activities
• The duration of time the activities will take
• Explanation of risks and benefits
• Compensation and any limits to receiving it
• Protections and limits of confidentiality

Stay tuned for a blog post describing the consent process in MUCH greater detail!

Study Interventions and Procedures

Procedures Involved

The IRB reviewer should be able to read and understand exactly what you are proposing to do with participants. Let’s pretend you are conducting a randomized controlled trial (RCT). The RCT will evaluate the effectiveness of a novel blood pressure medication in hypertensive patients. This section should include the following details:

• Screening & Enrollment: Eligible participants (adults aged 40-65 with hypertension) will be screened and provide informed consent before study procedures begin
• Study Visits: Participants will be randomized to receive either the investigational drug (Drug A, 10 mg daily) or a placebo for 12 weeks, with follow-ups at Weeks 4, 8, and 12 to monitor blood pressure, medication adherence, and side effects
• Data Collection: Blood pressure readings, symptom diaries, and blood samples (baseline and Week 12) will assess treatment effects and safety
• Safety Monitoring: Adverse events will be recorded, and a Data Safety Monitoring Board (DSMB) will oversee participant safety
• Study Completion: At Week 12, final assessments will be conducted, and participants will receive follow-up care recommendations

For all study procedures, consider the five questions below:

• Who on the study team is conducting the specific procedure?
• What is the specific procedure?
• How will the specific procedure occur?
• When will the specific procedure occur?
• Where will the specific procedure occur?

It is only important to note how the data collected from the specific procedures will be analyzed.

Study Intervention Discontinuation and Withdrawal of Participants

 If a participant requests to withdraw from the study, the investigator should describe:

• The scenarios under which they will be able to delete the participant’s data
• The scenarios under which they will not be able to delete the participant’s data

For example, in a clinical trial assessing a new diabetes medication, the following scenarios would apply:

1. Data deletion allowed:
   • If the participant withdraws before any study procedures (e.g., before baseline assessments), their data can be fully removed
   • If withdrawal occurs before their data is incorporated into an analyzed dataset, identifiable information can be deleted upon request
2. Data deletion not allowed:
   • If the participant withdraws after study interventions have begun, de-identified data collected up to that point may still be used to maintain study integrity
   • If their data has already been aggregated or published, removal is not feasible

Participants will be informed of these conditions during the informed consent process, ensuring transparency.

Risk/Benefit Assessment and Safety Monitoring

Risk

Remember when we said IRB reviewers look at previous applications similar to the proposed research?

To reiterate, IRB reviewers when they are making a determination for your study with respect to risk (i.e., no greater than minimal risk or above minimal risk). Minimal risk (as defined by 45 CFR 46.102(j)) means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. When the proposed research has risks, the investigator must have risk mitigation measures in place.

For example, if you are conducting a study on the psychological impact of childhood trauma, the IRB reviewer will evaluate whether participation could cause emotional distress. They will then check if:

1. Potential distress was disclosed in the informed consent process.
2. Risk mitigation measures (e.g., access to mental health resources, optional breaks, or the ability to skip sensitive questions) are in place.

The key is ensuring that the potential benefits—whether direct (e.g., therapeutic insights for participants) or indirect (e.g., advancing trauma research)—outweigh the study’s risks.

Direct Benefit and Indirect Benefit

First, let’s define direct benefit and an indirect benefit:

Now, let’s look at a couple of examples:

• Direct benefit: In a behavioral intervention testing a new stress relieving technique, a direct benefit would be the participant experiencing symptom relief from applying said technique to their daily routine
• Indirect benefit: In a study on a new educational program, an indirect benefit could be the increased awareness of the topic among the wider community due to the research dissemination

It is also important to note that compensation is not considered a benefit.

Provisions to Monitor Participant Safety

Describe the plan to periodically evaluate the data collected regarding both harms and benefits to determine whether participants remain safe. The plan might include establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the sponsor.  Specify the conditions that trigger an immediate suspension of the research. Specify any state laws related to mandatory reporting.

Biohazard Containment

This section should describe the potential biological hazards associated with the study. It should outline the measures in place to ensure safe handling, containment, and disposal of biohazardous materials.

Key considerations

• Specify if the study involves the collection, storage, or processing of human-derived materials (e.g., blood, tissue, saliva, or other bodily fluids)
• Indicate if any infectious agents, recombinant DNA, or genetically modified materials are used
• Identify the biosafety level (BSL-1, BSL-2, BSL-3, or BSL-4) required for the study
• Confirm that research will comply with institutional biosafety protocols and CDC/NIH biosafety guidelines
  • If recombinant DNA is involved, state whether Institutional Biosafety Committee (IBC) approval is required
• Outline proper handling, labeling, and storage of biohazardous materials
• Specify protective measures, such as personal protective equipment (PPE) and engineering controls (e.g., biosafety cabinets, fume hoods)
• Describe approved methods for disposal of biohazardous waste, such as autoclaving, chemical disinfection, or incineration
  • Confirm compliance with institutional and regulatory waste management policies.
  • Provide procedures for responding to accidental exposures, spills, or contamination events
• Describe how incidents will be reported to biosafety officers, institutional review boards (IRB), and regulatory agencies if necessary

Compensation and Economic Burden Considerations

Compensation for Participation

As mentioned above, compensation is not a benefit. Rather, compensation is a token of appreciation for participating in the research. It is not required to provide compensation. If you do not plan to offer compensation, you would simply include a statement regarding this. If you do plan to offer compensation, ensure the following details are included:

• The amount of compensation
• The form of compensation (e.g., if it is a gift card, identify where the gift card is to)
• The justification for the amount of compensation
• When and how compensation will be provided to participants

It is important to note that IRBs are not reviewing the amount of compensation to determine if it’s “enough”. IRBs review compensation amounts to ensure the amount is not coercive. As we know from the section above, coercion can make any individual vulnerable in research.

Compensation for Research-Related Injury

This section should describe whether and how the institution or study sponsor will provide medical care and/or financial compensation for injuries that occur as a direct result of study participation. Consider the following when drafting this section:

• Specify whether the institution has a policy regarding treatment or reimbursement for research-related injuries.
• If the study is industry-sponsored, clarify whether the sponsor assumes financial responsibility for treatment of study-related injuries. Ensure alignment with the clinical trial agreement (CTA) and institutional policies.
• Define what is covered, such as:
  • Medical treatment for study-related injuries
  • Whether participants will be reimbursed for costs incurred
  • Exclusions (e.g., injuries from procedures intended for direct medical benefit)
• Specify if the institution or sponsor does not provide financial compensation beyond medical treatment
  • Ensure that this section aligns with the informed consent document and does not conflict with institutional liability policies

If applicable, include information on how participants can seek assistance in the event of a study-related injury (e.g., contact information for research oversight offices or legal resources).

Economic Burden to Participants

Describe any costs that participants may be responsible for because of participation in the research. If applicable, include whether medical insurance will cover costs.

Privacy, Confidentiality, Data Management, and Future Use of Data

Privacy and Confidentiality

First, let’s define the difference between “privacy” and “confidentiality”:

Now, this section of a research protocol is vital for ensuring ethical standards are upheld and participant trust is maintained. Below are key elements researchers should address to create a robust plan for protecting participant data:

• Outline how participant privacy will be safeguarded throughout the project
  • For instance, provide private and secure environments for interviews or survey completion
• Specify where and how all data types—paper, electronic, or multimedia—will be stored and managed
  • Data must be stored securely, such as in password-protected databases or locked filing cabinets in restricted-access areas
  • Highlight additional security measures like data encryption for electronic records
  • Clearly state who will have access to the data, limiting it to essential study personnel to minimize risk
• For studies involving audio or video recordings, specify the retention period and handling procedures
  • For example, recordings may be deleted after transcription and verification or within six months of collection
  • During retention, secure storage methods, such as encrypted drives or locked cabinets, should be employed to prevent unauthorized access
• If a master list or key is used to link participant identities to data, describe its management
  • Explain how it will be securely stored separately from study data (e.g., on a different encrypted server or in a separate locked cabinet)
  • Identify who will have access to the master list and ensure access is limited to essential personnel
  • Additionally, specify when the master list will be destroyed
• State the minimum retention period for study data, typically three years after project completion, as per regulatory requirements
  • Except for master lists or keys and audio/video recordings, which should be destroyed at the earliest opportunity, all other data should be securely retained until the retention period ends
  • To maintain confidentiality, include methods for secure destruction, such as shredding paper files or securely wiping electronic data
• If data will be shared or moved outside your institution, provide a detailed plan (such as a data use agreement)
  • Specify the type of data that will be shared, the recipient(s), the circumstances under which sharing will occur, and the timeline for these actions
  • Include any additional security measures to ensure data confidentiality during transfer

Data Management

For this aspect, the IRB reviewer will look for:

• A statement of the types of study data collected
• A statement of who has access to study data
• A statement of how data will be stored
• A statement of when data will be destroyed
• A statement of how study data will be de-identified (if applicable)
• A statement of how identifiable study data will be managed

Stay tuned for a future blog post regarding methods on how to de-identify your study data!

Future Use of Data

This section requires explanation only if you plan to share data outside of your institution. The investigator should provide a plan for any data movement or sharing outside of their institution. This section should also specify what data will be provided, to whom, under what circumstances, and when. This should also be disclosed in the consent form.

Protected Health Information (PHI), HIPAA Compliance, and HIPAA Authorization Waiver

This section should include:

• A description of the creation, use, and/or disclosure of protected health information (PHI),
• A statement whether HIPAA authorization will be obtained from all or some participants or a description of what alternatives will be used,
• List everyone who will have access to PHI (including IRB, sponsors, FDA, data safety monitoring boards, and others),
• A list of what PHI will be collected, used, and/or disclosed including the source(s), and
• Why PHI obtained for this research are the minimum information needed to meet the research objectives

Additionally, describe the plan to protect and store PHI from improper use and disclosure. It should also specify and justify the earliest opportunity to destroy PHI and how it will be destroyed.  If PHI will not be destroyed, provide a justification. 

You will also need to explain how the use or disclosure of PHI involves no more than minimal risk to the privacy of individuals. It should also state why the research could not be practicably conducted without access to and use of PHI.

or

If the study qualifies for a waiver of HIPAA authorization, provide information explaining why the research meets the waiver criteria at 45CFR164.512(i)(2)(ii).  Include the following

• If you are requesting a waiver for the entire project (authorization will not be sought from participants) or recruitment only (identify eligible participants who then sign an authorization),
• Whether the waiver will adversely affect the privacy rights of the participant,
• An explanation as to why the research could not be practicably carried out without the waiver, and
• An explanation that the research could not practicably be conducted without access to and use of protected health information

Sharing of Study Results and Incidental Findings with Participants

Describe whether results will be shared with participants or others (e.g., the participants’ primary care physicians) and if so, describe how the results will be shared. Types of results include:

• Study results
• Individual participant results e.g., results of investigational diagnostic tests, genetic tests, or incidental findings

Study Timeline and Locations

Study Duration and Timeline

Describe the expected number and duration of contacts/meetings/procedures. In addition to the time commitment for participants and include an approximate end date of the study (including data analysis). Include a diagram/table/graph if appropriate. Outline if participation increases the duration of clinical care.

Study Setting and Locations (Including International Research)

Describe all sites/locations where your research team will conduct the research (e.g., where recruiting participants, research procedures will be performed, etc.), including any external sites conducting analytical procedures with project data. Please note any affiliated sites taking part in the research (e.g., sites with an existing reliance agreement). If you will be receiving/sending data to and from another institution, indicate which institution.

If you will also be conducting research at or with international sites, assess the relevance of the research to the region/country and the local context that affects the research, such as cultural norms.  Explain the research teams’ qualifications/expertise for conducting research in the locale(s). Describe the plan for monitoring the international components of the research. Additionally, explain any site requirements, laws relevant to the research (e.g. GDPR, PIPL), or state department warnings regarding travel to the international location(s).

Multi-Site Research Considerations

This section should describe considerations for research conducted across multiple sites, ensuring consistency in study implementation and compliance with ethical and regulatory standards.

Key considerations

• Indicate whether each site will seek separate IRB approval or rely on a single IRB (sIRB) under NIH or Common Rule mandates
• Describe how protocol consistency will be maintained across all sites, including investigator training and adherence to standardized procedures
• Explain how data will be collected, stored, and transmitted securely across sites, ensuring compliance with HIPAA or international data privacy regulations
• Outline mechanisms for reporting adverse events, protocol deviations, and updates to the lead institution and IRB

Coordinating Center Research

This section applies if the study is managed through a coordinating center responsible for protocol oversight, data management, or regulatory compliance.

Key considerations

• Define responsibilities such as centralized data collection, regulatory submissions, monitoring, and reporting
• Explain how the coordinating center will interact with study sites, ensuring protocol compliance and consistency
• Describe how monitoring visits, audits, and data verification will be conducted
• Specify how safety data, protocol deviations, and regulatory reports will be handled across sites

Analysis and Statistical Considerations

Data Analysis Plan and Statistical Considerations

This section should provide an overview of the statistical methods used to analyze the study data:

• Indicate whether interim analyses will be conducted and any predefined stopping rules
• Define how endpoints will be analyzed, including primary efficacy and safety measures
• Describe the statistical power analysis used to determine the study sample size
• Specify statistical tests (e.g., t-tests, ANOVA, regression modeling) and any planned subgroup analyses
• Explain how missing or incomplete data will be addressed (e.g., imputation techniques)

Study Outcomes and Endpoints

This section should detail the primary and secondary outcomes measured in the study:

• Define the main outcome(s) that the study is designed to assess, ensuring alignment with the primary study objective
• Describe additional measures that support the study’s findings or provide further insights
• Outline when data for each outcome will be collected (e.g., baseline, follow-up visits)
• Specify if outcomes are based on objective assessments (e.g., biomarkers, imaging) or subjective reports (e.g., patient-reported outcomes)
• Ensure endpoints reflect clinically meaningful improvements beyond just statistical significance

We hope you found the second post of this blog-series helpful!