Writing and Implementing Clinical Protocols
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Who Should Attend
This course is designed for those responsible for writing and
implementing clinical research protocols for all phases of
development in:-
New Drugs
- Biologics
- Devices
- Approved Drugs
In addition, this course is recommended for all clinical
research personnel that advise on how clinical protocols are
to be adhered and referred to in the process of conducting
clinical research for global approvals.
Participants should have a good understanding and
knowledge of GCP.
Description
Achieving a successful clinical program is based on collecting
and evaluating precise safety and efficacy data that will form
the basis of information for product approvals by global
regulatory agencies.
Clinical protocol development is key for product approvals
that come under the jurisdiction of INDs, NDAs, BLAs,
ANDAs, and CTDs. The clinical process necessary to write
protocols that will meet new product development will be
presented along with detailed discussions of protocol
requirements for phases 1, 2, 3, 3b, and 4. Specific
components in protocol content will be detailed especially for
inclusion and exclusion criteria, valuations of safety and
efficacy, and specific requirements for reporting AEs and
ADRs via FDA regulations and EU Directives. Case Report
Form (CRF) development and content will be presented.
Discussions include regulatory components and sponsor and
investigator obligations in implementing clinical protocols. The
significance of investigator meetings, clinical site selections,
pre-investigator site visits (PISVs) and international research
programs, and a protocol workshop.