Templates
Explore template types
Downloadable templates are available for a variety of uses and research needs. If you have questions or need assistance accessing these files, contact our office.
Protocol templates
The templates below serve as starting points for developing your research protocol. If you have questions about the templates below, contact your IRB Coordinator.
Use this template when the research involves:
- Observations that contribute to the development of biomedical knowledge;
- Products regulated by the Food & Drug Administration (i.e., a drug, biologic, supplement and/or device); or
- Enrolling subjects via the University of Rochester Medical & Affiliates covered entity.
Use this template when the research involves:
- Collection of and/or interventions related to human attitudes, beliefs, and behaviors; or
- Systematic attempts to define/investigate methods, conditions, or other factors involved in teaching and learning.
Download the Social-Behavioral-Educational Research Protocol Template
Use this template when the research only involves:
- Secondary analysis of data and/or biospecimens; or
- Retrospective chart review.
Use this template when the research involves:
- Routine educational practices conducted in commonly accepted educational settings;
- Benign surveys, interviews, educational tests, or observations of public behavior;
- Benign behavioral interventions involving the collection of verbal or written information from adults only; or
- Evaluations of public benefit or service programs
Use this template to establish, create and maintain a research database, registry or repository. If the research involves using data/specimens from an established database, registry or repository, use the Specimen & Record Review Protocol Template above.
Use this template to request the use of an investigational product (drug, biologic, supplement or device) to treat a single patient or group of patients in a non-emergency setting. If research will be conducted, use the Biomedical Research Protocol Template above.
Best Practices
- Only identify the Principal Investigator in the heading (and mentor, for student research). Adding other Investigators/team members is not necessary and will require revision each time staff update.
- Ensure all content is consistent. Conflicting information prevents the IRB from validating the criteria for IRB approval have been met.
- To avoid inconsistencies, group content in a step-by-step format. Stick to the section headings identified in the template. Avoid repeating procedures/details (refer other sections when necessary).
- Complete all sections; enter ‘N/A’ if a section does not apply to the research.
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- Exception: When utilizing a protocol template to create a protocol addendum, remove all unnecessary sections; only include content that is not addressed in the primary protocol. Do not repeat information in the protocol addendum that is address in the primary protocol.
- Delete all guidance text prior to IRB submission. Guidance language is only meant to assist Investigators during the protocol development process. Thee protocol submitted to the IRB should be in a ‘final product’ state
- Review the questions posed in the Criteria for IRB Approval Guide as a ‘double-check’ prior to IRB submission.
Consent templates
The templates below serve as starting points for drafting informed consent documents. If you have questions, contact your IRB Coordinator.
- English Short Form (for translation purposes)
- Spanish Short Form
- Russian Short Form
- Mandarin Short Form
- Translator Attestation
Best practices
- All content must be written at an appropriate reading level. Health literacy and plain language resources are available on the web. Recommended resources include:
- Agency for Healthcare Research and Quality’s Informed Consent and Authorization Toolkit for Minimal Risk Research
- Center for Disease Control’s Simply Put
- Miner Library’s Health Literacy Webpage
- Multi-Regional Clinical Trial (MRCT) Center’s Clinical Research Glossary
- Information highlighted in yellow on the templates is guidance and must be addressed or deleted prior to IRB submission.
Study documentation templates
The templates and tools below serve as starting points;. they can be used to:
- Identify required study documentation;
- Draft and organize study documents;
- Track study procedures and activities; and
- Demonstrate compliance with your study protocol, federal regulation and institutional policy.
All templates are in Microsoft document format. Modify/customize templates to collect the information you need, based on the study protocol. Variations of these forms are also available from other research-related sites via web search.
If you have questions, email ohspqi@urmc.rochester.edu.
- Study Site File Contents Description: Use this guidance document to identify the types of study documentation that need to be maintained as part of a study file.
- Study Site File Template GCP: Use this zip file as a template for organizing site file documents for research subject to Food & Drug Administration regulations (involving drugs, biologics, supplements, and/or devices).
- Study Site File Template Non-GCP: Use this zip file as a template for organizing site file documents for research that is not subject to Food & Drug Administration regulations (e.g., research deemed exempt, social-behavioral-educational research, minimal risk biomedical research).
Reference our Study Documentation page for additional information.
- Adverse Event Log: Use this template to document the occurrence, assessment of, and measures taken to address adverse events.
- Concomitant Medication Log: Use this template to record information regarding medications individual subjects are taking.
- Consent Log: Use this template to document pertinent details about the consent process.
- Enrollment Log: Use this template to document, track and follow the process of enrolled study subjects throughout the course of the study.
- Investigational Product Inventory Log: Use this template to track when and how investigational product is used throughout the course of the study, from receipt, dispensing, return and destruction of the product.
- Laboratory Sample Log: Use this template to document laboratory samples collected from subjects.
- Signature & Delegation of Authority Log: Use this combined template to document duties/roles of individual study team personnel, as designated by the Principal Investigator (qualifications, expertise and training of all study personnel must aligned with their respective assigned duties) and to authenticate/verify the signatures of study team personnel against study documentation and their corresponding qualifications (signatures must be handwritten and original (do not use signature stamps)).
- Signature Log: Use this template to authenticate/verify the signatures of study team personnel against study documentation and their corresponding qualifications; signatures must be handwritten and original (do not use signature stamps).
- Investigational Product Temperature Log: Use this template to routinely record the temperature of investigational product storage space, in accordance with storage requirements defined by the study protocol.
- Subject Investigational Product Accountability Log: Use this template to record when and how much investigational product is dispensed to and subsequently returned by an individual study subject.
- Telephone Record Log: Use this template to document important conversations with the study sponsor (and their designees) and study subjects, concerning the conduct of the research, subject eligibility, adverse events, and compliance.
- Training Log: Use this template to document training of study team personnel.
- Inclusion/Exclusion Criteria: Use this template to document confirmation of subject eligibility.
- Physical Examination Form: Use this template to document the health history of a subject.
- Routine Study Visit: Use this template to document observations and procedures conducted during the course of the study, in accordance with the study protocol.
- Screening & Baseline Visit: Use this template to document screening and baseline visits, in accordance with the measures/procedures defined by the study protocol.
- CAPA Plan: Use this template following an incident of non-compliance and/or protocol deviation to document the nature of the incident and the measures taken to address the incident. This should minimally include what happened, the root cause of the error, corrective actions taken to address the incident, and preventative actions implemented to prevent future re-occurrence of the error.
- Data & Safety Monitoring Plan Documentation: Use this template to document the conduct of data and safety monitoring measures defined by the study protocol.
- Informed Consent Discussion Note: Use this template to document the consent process including, informing subjects about consent (disclosure of the elements of consent), assessing subject understanding, answering subjects questions, and the documentation of consent.
- Note to File (NTF): Use this template to document and address issues that arise during the conduct of the study.
- NTF for Consent Error: Use this template following an error in the consent process to document the error and the measures taken to address the error. This should minimally include what happened, the root cause of the error, corrective actions taken to address the incident, and preventative actions implemented to prevent future re-occurrence of the error.
Self-audit templates
The templates and tools below serve to assist study teams in reviewing the quality of their study documentation. Self-reviews may be conducted for general quality-related purposes or as a means to prepare for a quality improvement review, monitoring visit, audit or inspection. If you have questions, email ohspqi@urmc.rochester.edu.
Use this checklist assess whether consent been documented properly for a single singed consent form.
Download the Consent Form Checklist – Single Consent Template
Use this checklist to assess whether consent has been properly documented for multiple signed consent forms.
Download the Consent Form Checklist – Multiple Consents Template
Use this checklist to assess whether the research study site file is complete.
Use this template to ensure all required items are present in the research study site file (all items, regardless of type and/or funding, are required to be documented).
Use this template to ensure all required items are documented in the research study subject file (some items will not apply to all studies).