| Clinical and Translational Science Institute

Clinical Research Professionals Training Series

Monthly webinars to increase your clinical research knowledge.

The work of clinical research requires a fully trained and educated team, including clinical research professionals (CRPs). Such preparation ensures that we are all conducting clinical research studies with efficiency, safety, reliability and compliance with Good Clinical Practice (GCP), regulations and policies. CRPs are defined as those non-faculty staff who work in roles that operationalize clinical research, such as (but not limited to) clinical research assistants, clinical research coordinators, clinical research nurses and roles in data management, regulatory affairs and project management.

We have revitalized the CRP Training Webinar Series to better equip our clinical research workforce. We've listened, we've learned and launched a series tailored to meet the evolving needs of Clinical Research Professionals (CRPs) at every level.

Two Distinct Training Tracks - This two-track CRP training series provides a better and more targeted training experience for the clinician research workforce.

1. Clinical Research Professional – Advanced (CRP-Adv)

When: Second Friday of every month
Time: 9 - 10 a.m. ET via Zoom
Who: Experienced or advanced-level CRPs
What: Expert-led sessions focused on high-level topics and emerging trends
Bonus: 1.0-hour CE certificate provided

2. Clinical Research Professional – Fundamental (CRP-Fun)

When: Fourth Friday of every other month, beginning September 26, 2025
Time: 9 - 10 a.m. ET via Zoom
Who: New or early-career CRPs
What: Foundational topics with a focus on compliance and core competencies
Bonus: 1.0-hour CE certificate provided

We're building this series with YOU in mind. Have a topic you're passionate about or curious to explore? Let us know, we're eager to shape future sessions around your interests.

To get on the listserv for CRPTS offerings, contact Karen Carter.

Upcoming Sessions:

Clinical Research Professional – Advanced (CRP-Adv)

Occurs on the second Friday of every month from 9:00–10:00 a.m. ET via Zoom for experienced or advanced-level CRPs; a 1.0-hour CE certificate is provided.

January 9, 2026
Compliance of Research Studies
Karly Taylor, MS, CHRC and Cody Brennan, CCRP
Human, Animal and Laboratory Investigations (ERIK)

February 13, 2026
Change Management
Jessica Fritter, DHSc, MACPR, ACRP-CP, FACRP

March 13, 2026
Study Start Up and Study Termination
Grace Wentzel, CCRP

April 10, 2026
Radiation, Chemical and Biosafety Concerns
Dave Puska

Zoom Link Advanced

Clinical Research Professional – Fundamental (CRP-Fun)

Occurs on the fourth Friday of every other month from 9:00–10:00 a.m. ET via Zoom for new or early-career CRPs; a 1.0-hour CE certificate is provided.

January 23, 2026
JTF and the Clinical Research Profession:
Frameworks that Shape Us
Jessica Fritter, DHSc, MACPR, ACRP-CP, FACRP

March 27, 2026
Title and Speaker TBD

Zoom Link Fundamental

Independent Quality Checks/Audits

Review of study conduct early in the research process.

Independent Quality Checks/Audits Support we provide:

Review of Regulatory Documents
Review of Inclusion/Exclusion Criteria and Consent Documentation of all study participants
Source verification for up to two study participants
Full Quality Audit for Audit Preparation

Independent Quality Checks/Audits allow for review of study conduct early in the research process. This allows for direct constructive feedback, recommendations and training for the remaining study conduct.

Independent Quality Checks/Audits may also be completed towards the end of the study for a more extensive look at the study conduct, to prepare for an FDA inspection or sponsor audit.

Schedule a Quality Checks/Audits

When is an Independent Quality Check/Audit Needed?

Independent Quality Checks/Audits are suggested for newer researchers who are conducting their first research study. This allows a researcher to gain valuable insight on how their study is progressing.

Independent Quality Checks/Audits may also be requested by the study PI to evaluate the study conduct and prepare for an FDA inspection or sponsor audit. This request should be scheduled well in advance of a notice of inspection/audit.

Independent Quality Checks/Audits may be completed for clinical research studies funded through the NCATS UM1 awards.

Independent Safety Monitor

The CTSI can provide assistance with clinical research monitoring on investigator-initiated trials.

Independent Safety Medical Monitor Support we provide:

Physician Advisor to the protocol team/sponsor investigator on Safety Oversight for low risk Investigator Initiated Trials
Independent real-time safety monitoring through reviewing adverse events (including Serious Adverse Events) and safety reports
Independent Adverse Event assessment/attributions
Evaluation of individual and cumulative study data to make recommendations regarding the safe continuation of the study.
Detailed review of study related documents

An independent safety monitor’s primary responsibility is to provide independent safety monitoring in a timely fashion, by reviewing adverse event and serious adverse event details in real time, from discovery to event resolution. They will make recommendations and act as in an advisory role to the sponsor-investigator for investigator-initiated trials.

Request support for Independent Safety Monitoring

FAQs

Study Monitoring

The CTSI can provide assistance with clinical research monitoring on investigator-initiated trials.

This is a service under the CTSI Trial-CORE. These services are available to staff at both Ohio State and Nationwide Children's Hospital. At Nationwide Children's Hospital the CRC provides study monitoring services.

Templates and Guidance- If you have a research team we can provide Study Monitoring templates, monitoring plans and guidance on how to ensure you have a strong data quality assessment.
Staffing of Study Monitoring- An independent experienced staff member can be budgeted to provide regulatory oversight and source data verification paying special attention to the following items:
- Adverse Events
- Protocol Deviations
- Protocol specified Outcome Measures
- Regulatory Document Review
- Training Documentation
- Consent Process Documentations
- Inclusion/Exclusion Criteria Review

To learn more or request a consultation, email CTSI-info@osumc.edu.

Data Safety Monitoring Board (DSMB)

Everything you need to know to create a DSMB.

DSMB Support we provide:

Letter of Support (LOS) for grant applications, upon request
Detailed review of study related documents
Intake meeting with Principal Investigator (PI), DSMB Chair and DSMB program manager
Initial DSMB meeting with study team, DSMB members and NIH representatives, if applicable
Data and safety review meetings with study team, DSMB members and NIH representatives, if applicable
Executive meetings with PI and DSMB Chair
Ad hoc/prompt reviews for safety events
Study Terminations

Request support for DSMB by contacting the CTSI Regulatory Knowledge and Support.

The CTSI DSMB is a group composed of a DSMB Program Chair, a DSMB program manager, a biostatistician and two to three experts in the field of research being studied. Optional DSMB members may include a clinical trial methodology expert, patient advocate and a/or bioethicist. Voting DSMB members must be free of any significant financial, scientific and academic conflict of interest with the study and study PI.

FAQs

Essential Documents

Find essential documents that are used to evaluate the conduct and quality of clinical trials.

Essential Document Support we provide:

Essential Document Templates
Essential Document Consultations

Request support for Essential Documents by contacting the CTSI-Regulatory Team.

What are Essential Documents?

Required study related documents that are used to evaluate the conduct of a clinical trial and the quality of the data produced. These documents serve to:

Demonstrate the compliance of an investigator, sponsor and monitor with the standards of Good Clinical Practice (GCP) and applicable regulatory requirements
Assist with the successful management of the trial by the investigator, sponsor and monitor
Used for auditing/inspecting by the sponsor’s auditor or regulatory inspector(s)

The term essential document is defined by the International Council for Harmonization Good Clinical Practice E6 A2 (ICH-GCP E6A2) (PDF) and a detailed list of required essential documents can be found in section eight of that guideline.

Essential documents are commonly referred to as regulatory documents. Regulatory documents may also include predicate documents, which are documents required to be maintained by Title 21 Code of Federal Regulations (21 CFR) and that the FDA requires a company to submit to them as part of compliance for FDA regulated research.

What Kind of Media Should be Used for Essential Documents?

Essential documents may be electronic or paper. Some essential documents, such as source documents, may be stored as audio tapes, recordings or images.

If conducting FDA regulated human subject’s electronic essential documents should comply with 21 CFR Part 11: Electronic Records; Electronic Signatures and Part 11, Electronic Records; Electronic Signatures – Scope and Application.

Established electronic systems used for some or all essential documents by Ohio State Researchers include:

REDCap
Advarra eReg – currently available for CCC and COM
Advarra EDC – currently available for CCC and COM
DocuSign
Qualtrics
IHIS

Where should Essential Documents be Stored?

Essential documents should be stored in an electronic or paper-based site master file. The site master file should be established at the beginning of the research study and maintained throughout the study. Unless otherwise noted, essential documents should also be filed with the study sponsor or Contract Research Organization (CRO) in their trial master file.

Records regarding the location of the essential documents should be maintained by the sponsor and the investigator/institution. Additionally, identification of the storage system(s) used during the trial and archival process should include information related to document identification, version history and the search and retrieval process.

If conducting an Investigator Initiated Multi-Center Trial, the Sponsor Investigator should maintain a trial master file that includes the essential documents from each participating site and should ensure these documents are maintained throughout the duration of the study.

Ethical Considerations from a Regulatory Perspective

Important ethical considerations with regulatory support.

Ethical Support we provide:

Research Subject Advocate
Ethical guidance for protocol, research planning and consent development
Training and Educational Opportunities

Request support for ethical considerations from a regulatory perspective by contacting the CTSI-Regulatory Team.

What is a research subject advocate (RSA)?

A research subject advocate is independent of the research team who acts on behalf of a research participant.

An RSA can:

Address concerns regarding a subject’s experience in a research protocol, and can direct any questions, complaints or ideas for improvement of research practices.
Be present during the process of consent for high-risk studies, as advised by the Senate Advisory Committee for Human Research Protection.
Provide a research participant perspective while planning study protocols.

What Ethical Considerations should be Addressed During Research Planning and Protocol Development

Researchers should approach ethical considerations from a multi-pronged approach and should base their ethical considerations off the Belmont Report, respect for persons, beneficence and justice.

Researchers should consider ethical standards when developing their recruitment plan, identifying their target population, determining inclusion/exclusion criteria, obtaining informed consent, protecting subject confidentiality, identifying risk of harm and evaluating the risk/benefit ratio, and communication of the study results. Research should be based on scientific validity and social and clinical value.

Human subject research is required to undergo an independent review by an independent ethics committee, such as the Institutional Review Board (IRB).

ClinicalTrials.gov

Support to get your study registered on ClinicalTrials.gov.

Support we provide:

Determining if your study should be registered.
Identifying required consent language address the CT.gov registration
Guidance for protocol registration and result reporting
Troubleshooting for registration and result reporting errors
Providing quarterly communication reports to Department Chairs and Associate Deans of Research regarding problem records.

Request support with ClinicalTrials.gov registration, results reporting, or addressing problem records.

Additional Tools, Templates and Resources

FAQs

ClinicalTrials.gov (CT.gov) is a publicly available online clinical trial database that includes details about clinical trials and their corresponding study results. This database is owned by the National Institutes of Health (NIH) National Library of Medicine (NLM).
Federal Laws and various policies/guidelines mandate that specific clinical trials must be registered and have their results reported, including:
- Food and Drug Administration Amendments Act (FDAAA 801)
- 42 CFR 11 Health and Human Services (HHS) Final Rule
- National Institutes of Health (NIH) Policy on the Dissemination of NIH-Funded Clinical Trial Information
- International Committee of Medical Journal Editors (ICMJE) (2005) guidelines
CT.gov contains two interfaces, one is the publicly available interface which can be accessed at ClinicalTrials.gov, one is the back-end interface called, PRS, where clinical trials can be registered. The registration site can be accessed https://register.clinicaltrials.gov.
When logging in to the PRS system please use the following organization names:
- For oncology studies: Ohiosuccc
- For all other studies: OhioU
Login to your PRS account and reference the PRS User Guide for detailed instructions on how to register your study, address problems and complete results reporting.
Data Elements that are specific to Ohio State research include the following:
- Protocol ID – This should be the Ohio State IRB #
- Secondary IDs – This should be the Federal Grant # or other ID. Include the name of the funding agency. For example: “R01-5555-555 NIH-NCATS”.
For each trial it will take approximately eight hours to complete the initial registration, approximately two hours for each update and approximately 60 hours for results reporting.
ClinicalTrials.gov training is available to all study team members to help identify and understand their responsibilities for:
- CT.gov registration
- CT.gov results reporting
- CT.gov required updates for clinical trials
Breakdown of Recommended Modules

To access the training:
1. Log in to CITI
2. Scroll down to the “Learner Tools for Ohio State University” box
3. Click “Add a Course”
4. Check “Protocol Registration and Results Summary Disclosure in ClinicalTrials.gov”
5. Click “Submit”
6. Find the course under “Courses Ready to Begin” and select “Start Now”
7. Complete the training modules
In addition to the CITI training module additional training opportunities are provided by the National Library of Medicine on the ClinicalTrials.gov Support and Training Materials webpage.

IRB Submission

Find numerous resources to help navigate the IRB.

IRB Submission Support we provide:

Addressing general IRB questions
Regulatory and ethical guidance for how to address or IRB modifications, for initial submissions, amendments, continuing reviews and event reports
Regulatory Training and Guidance for Regulatory Compliance Officers outside of the CCRM and CTO

Request support for Essential Documents by contacting the CTSI-Regulatory Team.

How do I utilize the Multicenter IRB Review?

The Ohio State University is committed to accelerating the IRB approval process for clinical research. This is illustrated through the establishment of:

IRB Authorization Agreements
IRB Reciprocity Agreements
Individual Investigator Agreements (IIAs)
Institutional Authorization Agreements (IAAs)

Ohio State has established IRB Authorization agreements to cede IRB review to the following external IRBs:

Advarra IRB - for review of some industry sponsored clinical trials
National Marrow Donor Program (NMDP IRB) - for review of studies sponsored by the Bone Marrow Transplant Clinical Trials Network (BMT CNT)
NCI CIRB – for review of select NCI-sponsored clinical trials
WIRB Copernicus Group IRB (WCG IRB) - for review of most industry initiated and sponsored clinical trials

Ohio State has an established IRB Reciprocity Agreement with Nationwide Children’s Hospital that permits Ohio State and Nationwide Children's Hospital to collaborate in the review and oversight of human subjects research that would otherwise require review by both organizations. This agreement applies when an:

Ohio State Investigator performs or is engaged in a study at Nationwide Children's Hospital
Nationwide Children's Hospital investigator performs or is engaged in a study at Ohio State

The CTSI has an established agreement between Ohio State’s Office of Responsible Research Practices and the eight institutions that compose the three CTSA sites in Ohio, to allow for one IRB to serve as the IRB of record for multi-center clinical research studies involving these CTSA-affiliated institutions which include:

The Ohio State University
Nationwide Children’s Hospital
University of Cincinnati
Cincinnati Children’s Hospital Medical Center
Case Western Reserve University
University Hospitals – Cleveland
MetroHealth
Cleveland Clinic Foundation

Read Ohio State’s IRB Guide to Establish Ohio State as Your Central IRB

Ohio State has also joined SMART IRB in support of the NIH Single IRB Review policy. SMART IRB is a platform designed to streamline and harmonize the IRB review process for multisite research. This effort was led by our CTSA consortium partner Harvard Catalyst, in collaboration with Dartmouth Synergy and University of Wisconsin-Madison. SMART IRB is intended to serve as a roadmap for institutions to implement the NIH policy on the Use of Single Institutional Review Board for Multisite Research.

SMART IRB

SMART IRB is a platform designed to ease common challenges and burdens associated with initiating multisite research and provide a roadmap for institutions to implement the NIH Single IRB Review policy. Through a flexible master IRB reliance agreement, standard operating procedures and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across the nation.

The CTSI aims to apply this “Reliant IRB” model to other collaborative research networks, with a goal to improve efficiencies in the IRB review and study implementation processes without compromising the regulatory and ethical environments that exist within any institution.

Subscribe to

Clinical Research Professionals Training Series

Upcoming Sessions:

Independent Quality Checks/Audits

When is an Independent Quality Check/Audit Needed?

Independent Safety Monitor

FAQs

Study Monitoring

Data Safety Monitoring Board (DSMB)

FAQs

Initial Meeting

Data and Safety Review Meetings

Ad hoc/Prompt Reviews

Executive Meeting

Essential Documents

What are Essential Documents?

What Kind of Media Should be Used for Essential Documents?

Where should Essential Documents be Stored?

Ethical Considerations from a Regulatory Perspective

What is a research subject advocate (RSA)?

What Ethical Considerations should be Addressed During Research Planning and Protocol Development

ClinicalTrials.gov

FAQs

PRS Administrators at Ohio State

Additional Resources

Institutional Resources

Regulations, Policies, and Guidelines

IRB Submission

How do I utilize the Multicenter IRB Review?

SMART IRB

Clinical Research Professionals Training Series

Clinical Research Professionals Training Series

Upcoming Sessions:

Independent Quality Checks/Audits

Independent Quality Checks/Audits

When is an Independent Quality Check/Audit Needed?

Independent Safety Monitor

Independent Safety Monitor

FAQs

When is an Independent Safety Monitor Needed?

Who can serve as an Independent Safety Monitor?

What is the difference between an Independent Safety Monitor and an Independent Medical Monitor?

Study Monitoring

Study Monitoring

Data Safety Monitoring Board (DSMB)

Data Safety Monitoring Board (DSMB)

FAQs

When is a DSMB Required?

How often will the DSMB Complete the Data and Safety Reviews?

What will Happen During the DSMB Meetings?

Initial Meeting

Data and Safety Review Meetings

Ad hoc/Prompt Reviews

Executive Meeting

Can an Alternative DSMB be Used?

Essential Documents

Essential Documents

What are Essential Documents?

What Kind of Media Should be Used for Essential Documents?

Where should Essential Documents be Stored?

Ethical Considerations

Ethical Considerations from a Regulatory Perspective

What is a research subject advocate (RSA)?

What Ethical Considerations should be Addressed During Research Planning and Protocol Development

ClinicalTrials.gov

ClinicalTrials.gov

FAQs

What is ClinicalTrials.gov (CT.gov)?

Benefits of ClinicalTrials.gov (CT.gov)

Which Studies Require ClinicalTrials.gov (CT.gov) Registration?

Federal Regulations – Applicable Clinical Trials (ACT)

NIH Requirements – All Clinical Trials

International Committee of Medical Journal Editors (ICMJE) – All Clinical Trials

Who is Responsible for Registration and Results Reporting

Where to Register an Investigator Initiated Trial (IIT) in ClinicalTrials.gov (CT.gov)

How to Obtain a PRS Account

PRS Administrators at Ohio State

How to Register an Investigator Initiated Trial (IIT) in ClinicalTrials.gov (CT.gov)

Where to Complete Additional Training

When Are Updates to the ClinicalTrials.gov Protocol Record Required?

What Happens if There is Non-Compliance with ClinicalTrials.gov Registration or Reporting?

Additional Resources

Institutional Resources

Regulations, Policies, and Guidelines

IRB Submission

IRB Submission

How do I utilize the Multicenter IRB Review?

SMART IRB

Protocol/Consent Development

Protocol/Consent Development

Comparative Effectiveness Research

Protocol Development

Consent Development

What is Informed Consent?

What is Required to be included in the Informed Consent Discussion and Consent Form?

Which Informed Consent Template should be used?