Activation (Stage 3) Clinical Research Lifecycle
From receipt of protocol approval(s) through initiation of participant screening
ActivationDuring this busy stage the research team and participating departments ensure all internal processes are in place in order to be able to execute the protocol. Including, but limited to:
- Finalizing data collection instruments
- Finalizing funding sources
- Executing contract
- Training team(s) on the protocol
- Communicating with and among centralized support groups / shared services.
CTRO research professionals can assist the PI in fulfilling his/her responsibility to ensure that all pre-activation activities are complete prior to screening and enrolling participants
During this stage the following centralized support groups / shared services may be engaged:
- Research Operations
- Clinical Research Unit (CRU)
- Investigational Drug Services (IDS)
- Biorepository
- Research & Grants Administration
- Post Award Activities
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- Training and Re-Consent Assessment
- Protocol Training Documentation
- Protocol Training / Transition Form Part A
- Protocol Training / Transition form Part B
- Protocol Training Agenda
- Training Attendance Sign-in Sheet
- Self-Study Training Documentation
- DOA Log
- DOA Log Sub-Site
- Delegation of Research Tasks Key
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Phase 2: Submission & Review
From submission through approval by all applicable internal and external committees.
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Phase 4: Conduct
From screening of first participant through completion of last participant last visit (LPLV)