Clinical Trials
Management Certificate
Certificate modules
To earn
the Clinical Trials Management Certificate, participants must
successfully complete each of the program's three modules:
Development:
Setting Up the Environment for Success
This
module provides an overview of the clinical and pre-clinical
processes involved in setting up clinical trials, and the
roles and responsibilities of those conducting and administering
these processes. Topics include:
- Ensuring
that a proposed investigative site is qualified and appropriate
for use in a clinical trial
- Recruitment
and retention of eligible study patients/participants
- Compliance
with U.S. regulatory bodies and ethical considerations:
safety, efficacy, privacy
- Comparison
of human clinical testing models with animal testing models
- Setting
up for collection and delivery of unbiased, concise, and
comprehensive scientific data
- Code
of conduct governing sponsors, sites, investigative personnel,
and other affiliated parties
- Case
studies of ethical and safety violations in clinical trials,
and their effect on new product development
Implementation: Carrying Through the Plan
This
module focuses on the processes involved in conducting safe,
thorough, and reliable clinical trials. Topics include:
- Monitoring
visits—purpose and importance of monitoring visits
from the site and sponsor perspectives; roles and responsibilities
of both site and sponsor in a successful outcome; essential
points of a comprehensive site visit from both a regulatory
and data management perspective; and what makes a highly
proficient monitor
- Obtaining
valid and reliable data—components of an appropriate
database, validation of associated systems, coding principles,
and the sequence of events leading to a database lock
- Emerging
markets—how they contribute to the challenges of new
product development, unique country/region mandates, effect
of newly emerging markets in relation to the future of scientific
experimentation
- Reporting
of safety concerns—how to appropriately report them
to regulatory agencies, regulatory timelines for reporting,
case studies
Integration: Creating the Package
This
module focuses on the steps necessary for completion and evaluation
of clinical trials processes. Topics include:
- Ensuring
that an investigative site has met all contractual and regulatory
obligations
- Follow-up
checklist: disposition of outstanding product supplies,
report data, etc.
- Evaluation
by the sponsor or agency regarding site and sponsor performance
- Audits
surrounding an NDA (New Drug Application) filing, random
and for-cause
- Introducing
a product to health-care practitioners and consumers: market
research, advertising principles, governmental rules and
regulations, product branding
- Effectively
reporting the outcome of clinical trials, including unbiased
reporting to potential consumers regarding the results,
limitations, and availability of the new product
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