Organization-Specific Module
Your site may wish to supplement the Clinical Research Coordinators (CRCs) course
with some organization-specific details and links so as to give the course a somewhat
more personalized feel. For each of these prompts, consider if it is something you want
to share specifics for with your clinical research professional population, which includes
CRCs. If so, please provide the appropriate text and/or link. If not, please leave blank.
Please feel to add additional categories. You are encouraged to avoid providing
individual names from within the organization and instead consider providing
departmental level information.
Introduction
Any welcome or introductory text you want to share.
Regulations
List and link any must-read regulations, such as 45 CFR 46 and/or 21 CFR 50.
List and link any relevant state and local regulations, including those governing when
minors reach age of majority
Institutional Policies and Standard Operating Procedures (SOPs) (in general)
List and link research-specific policies and SOPs necessary for CRPs to effectively
conduct research.
Where and how do researchers submit to the Institutional Review Board/Independent
Ethics Committee (IRB/IEC)? What is required before this can be done? Some
categories to consider include:
o Human Research Protection Program (HRPP)-related
o IRB-related (including collaborative sites, memorandums of
understanding, central IRBs)
o Institutional approvals
o Conflict of interest (COI)-related
o Education and training (what is required and where/how to document)
o Consent, assent, short-form consenting, translation
o Emergency use
o Quality Improvement/Quality Assurance programs or systems
Access
Are there any systems that the researchers need to gain access to? What are the
procedures for doing so? Is access to a centralized system for medical records
required? What training is available on the use of such systems?
Forms and Templates
Do you provide forms or templates for the development of protocols and/or consent
documents? Where are these housed? Is their use required or are they provided only
for reference or as-needed?
Grants and Contracts
What is your process for submitting grants? Do requests have to go through a central
entity? Describe any organization-specific requirements for grants submissions
and/or budget and contract approvals. Include links to any relevant policies and/or
SOPs. Other related items of consideration to discuss:
What are your processes pertaining to account setup and opening, chargeback
and reimbursements, and utilization of shared resources?
IRB Submissions
What are the procedures for working with your IRB? Do they have specific timelines to
follow? What requirements does the IRB have for study staff (for example, COI,
training)? What is the application process? Is there an electronic submission system?
How does one set-up an account if there is an electronic submission system?
Training Requirements
How do you determine the minimum necessary training that must be completed before
someone can be added to a research protocol? Where/how is this completed and what
(if anything) must be done to show compliance?
Curriculum Vitaes (CVs)/Licensure Documentation Requirements
How often do you need to update CVs? Where and how are they filed? Do you keep
licensures together with the CVs, and what are your practices for keeping this up-todate?
Consents
What policies/SOPs govern consenting? Are there specific templates to be used? What
grade level do you require consent documents to be written to?
Is there any language required to be included in the consent form, such as for HIPAA
and or inclusion in ClinicalTrials.Gov?
At what age does your organization require a separate assent form?
When does your organization require a witness? What specific requirements are there
for when a witness is used?
Do you have specific determinations as to when translation is required? What
resources are available for translating consent documents?
Financial Tracking
Does your organization have policies governing the compensation of research
participants? How do you determine acceptable, non-coercive payment amounts?
How is payment handled (for example, debit cards, gift cards, cash, checks)? What are
the tracking requirements?
Progress Reporting
What policies/SOPs govern progress reporting? How is this accomplished at your
organization? To whom do progress reports go?
Problem / Safety Reporting
What policies/SOPs govern the reporting of adverse
events/deviations/violations/unanticipated problems? To whom do such reports go?
Resources
What resources are available to assist researchers if they need assistance? Do you
have a Clinical Trials Office and/or a Clinical and Translational Science Award
facility?
Noncompliance
Is there a mechanism in place for reporting research non-compliance? Is it
anonymous? Links to institutional compliance office(s).
Regulatory Assistance
Are regulatory requirements maintained centrally or within the research team? Who
should the researchers contact with questions about following the regulations (for
example, an internal IRB support staff)?
Who should researchers contact if they have any questions about what they learn in
this CRP training module?
What other training resources are available to researchers in-house?