Clinical and Translational Science Institute
Advancing today’s discoveries to improve health for all.

External Trainings

Woman sitting on couch and studying

External Trainings

Available trainings for CRPs outside of Ohio State.

DIAMOND Platform

The DIAMOND Platform (Michigan Institute for Clinical and Health Research) was designed to provide a vehicle for CTSA-funded institutions to share clinical research trainings.  These trainings or contact links are uploaded and mapped to the Joint Task Force Competency Framework and learner levels. Learners can search courses by domain or topic. Users can also upload courses.

eMPACT Platform

The eMPACT Platform (Georgia CTSA) offers a pre-learning assessment that offers suggested courses for CRPs.

CRP Degree Programs

Student studying. Quote in background reads "making dreams a reality."

CRP Degree Programs

The Ohio State University offers multiple undergraduate, certificate and masters programs in clinical research.

Undergraduate

female undergrad researcher in white lab coat testing two young women on a treadmill

Clinical Trials Sciences Certificate (13 Credit hrs)

This program offers current undergraduate students’ opportunities to graduate with a clinical research certificate, a credential that may enhance employment in the clinical research enterprise.

Upon completion of this certificate, students will be prepared to:

  • Systematically apply understanding of regulations, bioethics, design and launch of clinical trials of investigational products.
  • Apply data and project management to support quality improvement and monitor clinical trials activities.

Post-BS/Post-Master's Certificate

female researcher checking the heart rate of another woman wearing all black

Clinical Research Management Certificate (12 Credit hrs)

This online graduate-level Clinical Research Management certificate will provide you with a broad foundation of knowledge and skills in human subjects’ research regulations, conduct, management and leadership and meets the internationally recognized Joint Task Force for Clinical Trial Competency framework. The courses are offered 100% online and asynchronously.

Graduate

male researcher in a white lab coat is helped by his assistant in collecting a blood sample

Master of Clinical Research (36 credit hrs)

The Master of Clinical Research is an interdisciplinary graduate degree program offered 100% online. The program was recently accredited by the Commission on Accreditation of Allied Health Education Programs. The curriculum is mapped to the Joint Task Force for Clinical Trial Competency offering specializations in Clinical Research Management and Regulatory Affairs. 

two female graduate researchers testing fluid in a tube

Master of Science Translational Pharmacology (30 credit hrs)

This multidisciplinary online curriculum is designed for recent graduates and professionals interested in a career in clinical and translational pharmacology, specializing in clinical trial design or preclinical toxicology and safety pharmacology studies. Choose from one of two specializations: Toxicology and Safety Pharmacology or Clinical Pharmacology and Clinical Trial Design

For more information on the GIS in Biomedical Clinical Translational Science Specialization contact Stuart Hobbs.

CITI Training

woman sitting and studying

CITI Training

Ohio State requires all faculty, staff, trainees and students eligible to conduct research to be trained in the Responsible Conduct of Research (RCR) through the online Collaborative Institutional Training Initiative (CITI) RCR course every four years.  Depending on the grant type or funding, additional courses may be required.

Beginning in 2024, in alignment with federal requirements and the university’s shared values, this course must be completed every four years within 60 days of assignment and is required of:

  • all those eligible to conduct research, including faculty, staff, trainees and students, regardless of funding source
  • all those who have completed some form of RCR training but not the CITI RCR course

Required CITI training for CRPs at Ohio State includes:  Human Subject Protection (HSP), Good Clinical Practice (GCP) and Responsible Conduct of Research (RCR).

Access Trainings for The Ohio State University

Additional CITI training is also available for you through the Ohio State CITI:

  • Social and Behavioral GCP Training
  • CRC Foundations Course
  • CRC Advanced Course
  • Clinicaltrials.gov Protocol Registration and Results Summary Disclosure 

Login to CITI using Single Sign On (SSO) to access these courses.

Local Ohio State Departments may have additional training requirements based on your role.

Certification Exams (ACRP, SoCRA)

Two nursing students studying outside

Certification Exams (ACRP, SoCRA)

Membership and obtaining professional certification demonstrate knowledge and competency in performing the varied duties of a Clinical Research Professional and can have positive effects on your role progression.

CRPs have multiple opportunities for certification from several organizations: the Association of Clinical Research Professionals (ACRP), Society for Clinical Research Professional (SOCRA), International Society of Clinical Research Nurses (IACRN) and Regulatory Affairs Professional Society (RAPS). 

For more information on certification opportunities, please visit:

ACRP Ohio Chapter logo
ACRP Clinical Research Coordinator Certification (CCRC, CCRA, ACRP-CP)
SOCRA for Clinical Research Excellence logo
SOCRA Clinical Research Professionals Certification (CCRP)
Regulatory Affairs Professionals Society (RAPS) logo
RAPS Regulatory Affairs Certification (RAC)
International Association of Clinical Research Nurses (IACRN) logo
International Association of Clinical Research Nurses (CRN-BC)

Karen Carter

Associate Director Education

Education and Training

Email

karenk.carter@osumc.edu

Phone

614-366-3887

Karen Carter headshot

Clinical Research Professionals Training Series

Student studying in Ohio Union

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.

The Clinical Research Professional Training Series (CRPTS) is a monthly webinar held on the second Friday of the month from 9 - 10 a.m. EST via Zoom. Each month speakers will present topics of interest that are mapped to the Joint Task Force (JTF) for Harmonized Clinical Research Core Competencies and ICH E6 (R2). Attendees can earn 1.0 hr ACRP or SoCRA Continuing Education points and establish valuable peer connections across Ohio State and Nationwide Children’s Hospital. 

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

In 2025 we will have the following topics and speakers:

March 14, 2025: Gene Therapy with Andrea Davis 

We will explore the exciting field of Gene Therapy from a surgical standpoint. And highlight exciting new therapies emerging at Ohio State. 

April 11, 2025: Bioethics in Research with Sarah Stenger

We will discuss the importance of ethics in research and how they prevent the atrocities of the past. We will also discuss how ethics affect the use of digital technologies and data science. 

June 13, 2025: Implementing a Statewide Research Project with Grace Maynard-Wentzel

Join us to learn about SOAR (State of Ohio Adversity and Resilience) a new state-wide research study that will examine the risks that may lead to persistent distress, mental illness, substance use disorders, overdose or suicide.              

July 11, 2025: Study and Site Management with Jessica Fritter and Amy Bartlett

Proper study oversight and proper management are essential in Human Subject research studies to ensure subject safety and quality outcomes. We will discuss best practices in our ever-changing landscape. 

August 8, 2025: Data Management and Informatics with Amanda Tan, NIAID

TBD

Note: We will not have a CRPTS webinar in May 2025, due to our FDA Symposium. 

Registration for CRPTS trainings

Independent Quality Checks/Audits

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

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

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)

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

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.

Subscribe to