Incorrectly or incompletely documenting study procedures can slow down regulatory approval, lead to protocol deviations, and cause errors during research implementation. While investigators usually know exactly how they plan to conduct their study, translating those plans into a crystal-clear written protocol is a common hurdle.
In this article, you’ll discover the key elements that regulatory bodies—like the Institutional Review Board (IRB)—look for, along with practical strategies for creating clear, comprehensive descriptions that streamline review and support successful study implementation.
What do study procedures cover?
While there is no single universal definition of a study procedure, the term generally refers to any activity conducted for research purposes involving participants, their data, or their biospecimens. Study procedures may include:
- Interventions
- Assessments
- Observations
- Data collection activities
- Safety monitoring
- Eligibility screening
- Follow-up activities
What are reviewers looking for?
Study procedures may be one section of the protocol, but they form the bedrock of your entire study design. Because they dictate exactly how the science will happen, these procedures face thorough evaluation from scientific committees and IRB panels—often requiring significant clarification or modification before securing approval.
- Scientific reviewers look for study procedures that clearly correlate to the study aims, hypotheses, outcomes, and a clear, full, and comprehensive analysis plan. They may have concerns if it appears that necessary procedures are missing or irrelevant procedures are planned.
- Ancillary review groups—such as Fairview Research Administration or the Institutional Biosafety Committee—rely on the protocol, especially the study procedures, to determine if their groups’ requirements for research have been satisfied.
- The IRB panel or designated reviewer will determine if the study meets regulatory requirements, using the study procedures to assess the burden posed to participants and the potential risks associated with participation relative to any possible benefits. Many regulations include specifications that can change the risk determination of your protocol, so specificity is important.
How well-documented study procedures set your study up for success
- Expose operational challenges early: Early identification of staffing requirements, workflow constraints, technology needs, heavy participant burden, or recruitment barriers helps anticipate and mitigate potential issues before launching the study.
- Align your protocol and study documents: Clear procedures improve consistency—from screening procedures and the statistical analysis plan to your recruitment materials and consent forms—reducing the need for IRB clarification or post-approval study modifications.
- Support other study processes and supporting materials: Well-described study procedures are easily translated into clear project workflows, standard operating procedures, and training materials.
- Better ensure staff adhere to the study plan: Giving your team an unambiguous roadmap standardizes how delegated tasks are performed and minimizes protocol deviations.
- Safeguard data quality and reproducibility: Consistent implementation of study procedures leads to better data quality, supports reproducibility, and strengthens confidence in study findings.
Capturing the complete participant experience
A common mistake is focusing only on the primary study intervention or data collection activity while overlooking the many research procedures that occur before and after that event. Remember that study procedures occur from the time a potential participant is approached and provides consent through the end of the study, including:
| Step | Purpose | Examples |
|---|---|---|
| Screening and consent | Sets the stage for that first moment of participant interaction. |
|
| Randomization and blinding | Details the process, method, and structure of the randomization plan. |
|
| Run-in period | Prepares for active participation. |
|
| Active participation | Intervention or interaction with participants that directly inform the study outcome or endpoints. |
|
| Inactive participation | Indirect interaction or observation that informs the study outcome or endpoints, or monitors safety and efficacy. |
|
| End of study | Activities required to end participation. |
|
When
| Question to ask | Essential elements to capture |
|---|---|
| When will procedures take place? | This is particularly important to detail in complex studies—for example, detailing the timing in relation to other study procedures. Include visit windows (plus or minus X amount of days) to give yourself flexibility, as appropriate for your study. |
| When were data created, or from when will data be collected? | Be sure to specify the type of data, including whether it is retrospective (already in existence at the time of IRB submission) or prospective (data does not yet exist at time of IRB submission). |
Why
| Question to ask | Essential elements to capture |
|---|---|
| Why is a particular research procedure conducted? | Many procedures are more obviously related to the research question, but some procedures, like pregnancy tests or blood draws, are completed during screening to help determine participant eligibility. Others may be conducted for safety monitoring or secondary analyses. |
It is critically important to ensure that each procedure is clearly connected to your research questions, hypotheses, and study endpoints. Reviewers will raise questions if procedures appear unrelated to or don’t adequately assess the study objectives. Explaining why a procedure is necessary not only strengthens scientific justification but can also help assess participant burden and balance the risk-to-benefit ratio.
The bottom line
To ensure your study procedures are complete and comprehensive, all five of the W’s must be described for every stage of the study. Omitting even one detail or element can lead to confusion or implementation errors. The same level of rigor and detail should be applied universally across all study procedures, regardless of their perceived risk or relatedness to the study intervention.
Ultimately, well-documented study procedures do far more than satisfy an IRB requirement—they are the foundation for high-quality, ethical, and scientifically sound research. By investing time in clear descriptions in the development stage, you will help reviewers understand the study design, ensure consistency across research documents, support staff training and study operations, and reduce the risk of protocol deviations or regulatory concerns.
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