Study Team Member Training & Resource Reference List
NOTE: This training and resource reference list is provided as a guide to facilitate study team member training. In consideration of study team member training, OHSP recommends reviewing the role-specific “Basic Training Checklist” documents provided on the OHSP Research Education & Training website as a first step. The checklist should then be modified to meet departmental and/or study team needs by: 1) eliminating training elements that are not applicable; and 2) inserting additional training elements from the comprehensive list below as needed.
University-required training is identified with asterisks in the applicable activities’ description below. In the event that you are unsure whether the element is required, please contact the element’s department/division directly (e.g., if you are unsure whether HIPAA Privacy and Security training is required, please contact the Research Privacy Officer directly).
If you would like guidance on developing departmental and/or study team training standards, contact Kelly Unsworth at (585) 275-5244 or .
Contents:
- General Review MaterialsTraining Opportunities: The documents and resources provided in this section are publicly available via the internet. They include federal/international guidelines and training opportunities on the conduct of human subject research. While these documents are not specific to the University of Rochester, elements within this subset may be important to review based on one’s role in a study or the nature of a specific study (E.g., It may be helpful for new study coordinators with no prior experience to review the “CTSA Research Coordinator Taskforce: Training Elements of Human Subjects Research Coordination” just as Principal Investigator’s may find it helpful to review the FDA Guideline on Investigator Responsibilities.)
- University-Specific Review Materials & Training Opportunities: The documents and resources provided in this section are specific to the University of Rochester. They include policies, guidelines and training opportunities administered by various components of the University’s Human Research Protection Program.
- Additional Resources, Research Services & Ancillary Committees: The elements identified in this section constitute resources, research services and ancillary committees within the University of Rochester. While these are not specific training opportunities, they may be important to review with new staff depending on their role and the type of research they conduct.
Activity/Resource / Hyper-
link
General Review MaterialsTraining Opportunities
Office for Human Research Protections (OHRP) Website
OHRP is the office within the Department of Health & Human Service (DHHS) that provides oversight of the implementation of DHHS regulations concerning human subject research and leadership in the protection of the rights, welfare and wellbeing of subjects. The Research Subject’s Review Board (the Institutional Review Board for the University of Rochester) is registered with OHRP and maintains a Federalwide Assurance (FWA) with OHRP. Through the FWA, the University of Rochester provides written confirmation to DHHS that it will comply with the requirements set forth in 45 CRF 46. Note that within the FWA, the University of Rochester has elected to apply the Common Rule to all human subject research regardless of the source of support.
OHRP provides multiple education materials, including: / Link
- Policy & Guidance Documents (e.g., Informed Consent Guidance, Checklists & FAQs; Investigator Guidance FAQs; Guidance on Certificates of Confidentiality; Guidance on Research Involving Children; Human Subject Regulations Decision Trees)
- Protecting Human Subjects Video Series
- Online Training Modules
- Educational Videos (e.g., Research Use of Human Subject Biological Specimens & Other Private Information; Reviewing & Reporting Unanticipated Problems and Adverse Events; General Informed Consent Requirements; Complex Issues with Research Involving Vulnerable Population)
Food & Drug Administration (FDA) Clinical Trials & Human Subject Protection Website
FDA is an agency within the Department of Health & Human Service (DHHS) that provides oversight of human subject research involving investigational products (i.e., drugs, devices and biologics). While FDA is an agency within DHHS, FDA has separate regulations that all studies involving investigational products, regardless of sponsorship, must be adhered to.
FDA provides multiple educational materials, including: / Link
- Information Sheets (e.g., Recruiting Study Subjects, Payment to Research Subjects, Informed Consent, Emergency Use of Investigational Drugs/Biologics, Treatment Use of Investigational Drugs, Drug Study Designs, FAQs – Statement of Investigator, FAQs – Medical Devices, Significant and Non-Significant Risk Devices, FDA Inspections of Clinical Investigations)
- Guidance Documents (e.g., Establishment and Operations of Clinical Trial Data Monitoring Committees for Clinical Trial Sponsors, Data Retention With Subjects Withdraw from FDA-Regulated Clinical Trials, Investigational New Drug Applications, Investigator Responsibilities, Oversight of Clinical Investigations, Adverse Event Reporting to IRBs, Q&A on Informed Consent Elements)
- Bioresearch Monitoring Program Manuals
- CDER Learn (FDA’s Center for Drug Evaluation and Research educational website)
- CDRH Learn (FDA’s Center for Devices and Radiological Health educational website)
Global Health Training Centre
The Global Health Training Centre is a central research training hub administered by the Global Health Networks. The site offers multiple on-line training short courses, as well as modular courses – all free-of-charge. Courses include: Introduction to Clinical Research, ICH Good Clinical Practice, The Research Question, The Study Protocol, Data & Safety Monitoring Boards for Clinical Trials, Introduction to Informed Consent, Introduction to Data Management for Clinical Research Studies, Introduction to Collecting and Reporting Adverse Events, Introduction to Reviewing Genomic Research, Essential Elements of Ethics, and Research Ethics. / Link
Good Clinical Practices Training (CITI Program)
Though not required, this course may be completed in addition to the required human subjects research training through the CITI Program. To complete the course, login to CITI (using the login information created at the time of human subjects training completion) and select “Add a Course or Update Learner Groups” from the Main Menu. From there, select “Human Subject Protection” and then “Good Clinical Practices”. / Link
International Conference on Harmonisation Good Clinical Practice Guidelines
The International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use, commonly referred to as ICH, has established good clinical practice (GCP) standards that have been adopted internationally. While the FDA has adopted these as guidance, compliance with GCP guidelines (regardless of federal oversight) ensures subject safety, protocol compliance, proper study team training and adequate study documentation. / Link
Office of Research Integrity
The Office of Research Integrity is the office within the Department of Health & Human Service (DHHS) that oversees and directs Public Health Service (PHS) research integrity activities, including the education and training in the responsible conduct of research. Multiple resources are available on their website, including: / Link
- Introduction to the Responsible Conduct of Research
- Data Management Resources & Training
- Mentorship Resources & Training
- Publication/Authorship Resources & Training
- Research Misconduct Resources & Training
- The Research Clinic (an interactive training video, available through DHHS’s Office of Research Integrity, educates clinical and social researchers on both human subject protections and research misconduct. The video allows trainee’s the opportunity to play the role of 4 distinct characters, dealing with human research protections from differing perspectives)
Teaching the Responsible Conduct of Research in Humans (RCRH) by UCLA (Stanley Korenman, MD)
This e-book, available through DHHS’s Office of Research Integrity, employs problem-based learning techniques to explore ethical issues concerning human subject research. The e-book includes chapters on ethics, research in humans, study design, conflicts of interest, international clinical research, monitoring research, genetics & stem cell research and malfeasance & misconduct. / Link
TransCelerate’s Principal Investigator Oversight Informational Program
This is an informational program outline the basic components related to Principal Investigator oversight of clinical trials. / Link
Training Elements of Human Subjects Research Coordination (CTSI Research Coordinator Taskforce)
This document, developed by the CTSA Research Coordinator Taskforce, provides a broad overview of human subject research coordination at academic medical centers including essential regulatory and protocol management elements. / Link
University-Specific Review Materials & Training Opportunities
Administration & Finance Policy on Retention of University Records / Link
Environmental Health & Safety: OSHA Required Training
* Required for all staff working in labs or supervising lab personnel (customized training for Clinical Lab Personnel, Phlebotomists & Clinical Study Coordinators and Research Lab Personnel) / Link
Environmental Health & Safety: Shipping Biological Materials & Dry Ice Training
* Required for all staff shipping biological material (or transporting human/animal specimens in their own vehicle) / Link
HIPAA Policies, Procedures, Forms & Guidance / Link
- HIPAA Policy 0P25: Use or Disclosure of PHI for Research Activities
- HIPAA Procedure 0P25: Use or Disclosure of PHI for Research Activities
- HIPAA Research Activities Forms & Guidance
- Mobile Computing Device Security Standards
HIPAA Privacy and Security Training
* HIPAA Privacy and Security training may be required based on an employee’s role within the University. Requirement information can be found here: Link / Link
Human Subjects Research Training (CITI Program)
* Required prior to conducting any human subjects research / Link
OHSP Policies & Guidance Documents / Link
OHSP Quick Reference Guide / Link
OHSP Education & Training Framework / Link
- OHSP Orientation to Conducting Human Subject Research
- OHSP Research Boot Camp
- OHSP Core Training Modules 1-10
OHSP Monthly Seminar Series
OSHP conducts a monthly seminar series titled “Achieving High Quality Clinical Research”. Copies of seminar slides as well as video recordings of previous presentations can be found on the OHSP and CTSI websites. The following are selected presentations that are recommended for review: / Link
- Informed Consent: Federal Regulations, Institutional Policy & Good Practice
- Understanding Conflicts of Interest
- Data Storage for Research
- Non-Compliance
- CAPA Plans: Solutions, not Blame
- Understanding RSRB Review Processes to Improve Submissions
- OHSP Policy 901 – Investigator Responsibilities
- Planning for Your Plan: Data and Safety Monitoring Plan Development & Implementation
OHSP Supplemental Training Materials / Link
- Informed Consent Video Series – Part 1: Federal Regulations & Institutional Policy; Part 2: Vulnerable Populations: Part 3 – Good Practice
ORPA Clinical Trial Resources / Link
ORPA Blackboard Course: Overview of Clinical Research Billing Policy and Standard Operating Procedures (Course CT-01) / Link
ORPA Blackboard Course: Clinical Trial Finance – Budgeting and Negotiation (Clinical Trial Finance Course CT-03)
Note that this course is targeted for individuals dealing with clinical trial budgets. As such, applicability may be depend on departmentalroles and will not likely apply to faculty. / Link
ORPA Blackboard Course: UR Conflict of Interest Policy (Course UR ORPA COI Policy) / Link
Orientation Requirements for FDA Investigational New Drug Applications & Orientation to Medical Devices and the Requirements for FDA Investigational Device Exemption Applications (CTSI FDA Training)
* Required for investigators prior to any IND or IDE submissions (training is optional, but strongly recommended for study team members working on FDA-related aspects of the study / Link
Radiation Safety Training
* Required for all prospective users of radioactive material. / Link
ROSS (RSRB Online Submission System) Training
Training modules are provided on the OHSP website. Alternately classroom training is available the 3rd Monday of every month from 2-3pm in the OHSP Office (contact Suzanne Flanigan at x53050 on global to sign up) / Link
Study Coordinator Organization for Research and Education (SCORE)
SCORE is a group within the University of Rochester that provides support in research, continuing education and regular opportunities for networking for study coordinators and research staff. SCORE holds monthly noon-time meetings that are open to all faculty and staff. Additional resources as well as information regarding their mentor program are available on their website. / Link
UR Leadership Development Program / Link
Additional Resources, Research Services & Ancillary Committees
CTSI’s Research Help
The Clinical & Translational Science Institute’s Research Navigator Program acts a central research help desk for faculty and staff. The program aims to guide researchers to relevant resources, tools and collaborators and assists with required processes. This includes: / Link
- Opportunities to seek support in designing studies
- Finding collaborators or mentors to provide guidance
- Securing funding
- Creating “Customized Action Plans”
- Assistance with subject recruitment & retention strategies
- Utilizing eRecord for research
- Obtaining access to data through University-specific information systems
CTSI’s Office of Regulatory Support
The Office of Regulatory Support provides support to investigators with the navigation of and compliance with a range of human subjects research requirements, including: / Link
- FDA Investigational New Drug application support and guidance
- FDA Investigational Device Exemption application support and guidance
- Support for ClinicalTrials.gov study registration
- Research subject advocacy and informed consent process
- Support for Data & Safety Monitoring Plan (DSMP) compliance
- 21 CRF 11 compliance
Clinical Research Center
The Clinical Research Center (CRC) provides an optimal setting for clinical investigators to conduct safe, controlled, inpatient and outpatient studies. The CRC not only provides space to study team to conduct research but also offers nursing, nutrition services, phlebotomy and DEXA scanning services. Review and approval of all study protocols utilizing the CRC is required. / Link
Clinical Trials Office – Cancer Center
Review and approval from the Clinical Trials Office is required for all hematology/oncology-related studies proposed at the University of Rochester. The committee will review the protocol for scientific merit and potential conflicts with other studies. Contact the Clinical Trials Office at 275-5345 for additional information. / N/A
Clinical Trials Processing Laboratory (URCTPL)
The University of Rochester Clinical Trials Processing Laboratory is a fee-for-service core resource that supports clinical trials and basic science research. The laboratory provides technical services including processing of blood and tissue samples and DNA extractions for PI-initiated, pharmaceutical and NIH-funded clinical trials, as well as shipment of specimens according to study protocols. Contact Christopher Lane (on global network) for more information. / N/A
Cold Storage Core (CSC Facility)
The Cold Storage Core (CSC) Facility is an alarmed and environmentally controlled area that provides a secure on-site environment for long-term storage of research materials at the main medical center campus. UR facilities also maintains four spare -80oC freezers in the CSC for emergency use by UR investigators. Contact Christopher Lane (on global network) for more information. / N/A
Environmental Health & Safety: Waste Management
The Sanitation Office within Environmental Health & Safety is responsible for helping the University achieve and maintain a healthful environment. Improper handling or disposal of certain types of waste could be illegal and create unsafe conditions. The Sanitation Office’s website provide a waste management matrix identifying different types of waste and their proper method of disposal. / Link
Emergency Medicine Research Committee
Review and approval from the Emergency Medicine Research Committee is required for all studies involving Department of Emergency Medicine staff as well as those planning to enroll subject through the Emergency Department (ED). The committee will assess the protocol’s scientific merit as well as the feasibility of conduct in the ED. / Link
Emergency Department Research Associate Program
The Emergency Department Research Associate (EDRA) program is a resource available to investigators who wish to access potential subjects seen in the Strong Memorial and Highland Hospital Emergency Departments. Through this program, Research Associates are available to assist in the screening, recruitment and enrollment of these subjects. / Link
Human Use of Radiation Committee Website
The University of Rochester’s Radiation Safety Unit is responsible for all activities dealing with radioactive material and radiation producing equipment. As such, protocols involving human subject exposure to ionizing radiation may require by the Unit’s Human Use of Radiation Committee (HURC). / Link
Imaging Sciences Clinical Trial Services
The Department of Imaging Sciences provides a variety of radiologic services to address clinical trial needs , including imaging price quotes and requisition set-up as well as image management. / Link
Institutional Biosafety Committee Website
The University of Rochester's Institutional Biosafety Committee (IBC) is a University-wide committee responsible for reviewing and approving recombinant DNA and biohazard research projects. Safety requirements and guidance documents for a variety of biological hazards found in UR laboratories as well as information regarding protocol review and approval is available on their website. / Link
Investigational Drug Service
Investigational Drug Service (IDS) provides clinical researchers with the support to assure safe and efficient conduct of clinical drug trials. IDS services include inventory control & storage, drug accountability, packaging & storage, drug information, drug dispensing and other special service (e.g., drug compounding). / Link
Miner (& River Campus) Library’s Data Management Support / Link
Miner Library e-Books
- Hackshaw, A. (2009). A Concise Guide to Clinical Trials. Hoboken, NJ: BMJ Books.
- Harrington, D. (2012). Designs for Clinical Trials: Perspectives on Current Issues. New York: Springer.
- Friedman, L., Furberg, C. & DeMets, D. (2010). Fundamentals of Clinical Trials. New York: Springer.
- Liu, M. & Davis, K. (2009). Clinical Trials Manual from the Duke Clinical Research Institution: Lessons from a Horse Named Jim. Hoboken, NJ: Wiley-Blackwell.
- Meinert, C. (2012). Clinical Trials Handbook: Design and Conduct. Somerset, NJ: Wiley.
- Turner, J. (2010). New Drug Development: An Introduction to Clinical Trials. New York: Springer
URMC Labs – Central Laboratory Services
URMC’s Central Laboratories is a full-service clinical trial central laboratory providing clinical and anatomic pathology services as well as full project management, data management and logistics to support multi-site trials. / Link
URMC Labs – Clinical Laboratory Services for Researchers
URMC Labs is committed to meeting the needs of researchers including price quotes for both clinical laboratory and anatomic pathology diagnostic services, laboratory set-up for studies (custom requisitions, report handling, specimen storage, and any special requirements), technical services (such as histology, immunocytochemistry, phlebotomy), and consultation with faculty experts regarding the development of an appropriate and effective testing menu. / Link
URMC Labs – Point of Care Testing
Point of Care Testing (POCT) is any laboratory test provided by an institution outside the physical facilities of a central laboratory. URMC’s POCT website provides information on approved POC testing, including policies and procedures that must be adhered to when conducting such testing. / Link
URMC Labs – Request for Human Tissue
Review and approval from Surgical Pathology is required for all studies utilizing slides or tissue from the URMC Labs Department of Pathology and Laboratory Medicine. Contact 276-4939 for additional information or refer to the “I need human tissue…” section on the webpage provided in the following column. / Link
Perinatal Research Committee
Review and approval from the Perinatal Research Committee is required for all studies involving pregnant women and newborns/infants in the normal nursery or neonatal intensive care unit at Strong Memorial Hospital or Highland Hospital. Submissions for review by the committee are completed through the RSRB Online Submission System. Contact 275-7480 for additional information or questions. / N/A
Rochester Center for Brain Imaging
The Rochester Center for Brain Imaging (RCBI) is a research facility offering a state-of-the-art 3T magnet for the purpose of conducting investigations using magnetic resonance imaging (MRI). The center also offers courses, summer research experiences and demonstrations for faculty and students. All protocols utilizing RCBI resources for human subject research require review and approval. Additional information can be found on their website. / Link
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