Step 2: Conducting a Cancer Prevention Clinical Trial
Start-up Activities
Start-up activities for a new study cover the activities that occur between the time a site is chosen to participate in a study and the time that the first participant is enrolled in the study.
The submission of the completed regulatory documents to the Sponsor will trigger investigational agent shipment to the site when a participant is identified for the study. Shipment of investigational agent can not occur until all required documents have been submitted. Sites must follow the DCP Guidelines for Submitting Clinical Drug Requests (doc, 33kb). Sites must follow the DCP Policy and Guidelines for the Transfer of DCP Supplied Investigational agents (doc, 24kb) from on DCP protocol to another within an institution. The DCP Transfer Investigational Agent form (doc, 48kb) must be used.
The purpose of the initiation visit is to meet with key staff at the lead organization who will participate in the conduct of the clinical trial, which will be monitored by the Westat Team. The staff will be oriented to the general aspects of the trial and discuss the roles and responsibilities of DCP, clinical site staff, and Westat Team staff. See Section 9.1.1 (pdf, 38kb) of the DCP Study Site Monitoring Manual for details.
Site preparation:
- Complete regulatory documentation
- Submit documents to Institutional Review Board and obtain IRB approval (protocol, informed consent form, investigator brochure, and advertising)
- Prepare drug storage area
Agent Supply:
- Submission of all completed regulatory documents to the Sponsor will trigger drug shipment to the study site
- Study agent may not be supplied to any other person for usage with out the Sponsor's permission
- Study site documentation should include shipping receipt, condition of study agent, dispensing information, study agent return information, etc
Study initiation documentation:
- Signed protocol/amendments
- Investigator and staff CVs or biosketches and licenses
- Budget and confidentiality agreement
- IRB approvals
- IRB membership
- Laboratory certification, Lab Director CV, and normal ranges
Study Materials at the Site:
- Screening checklist
- Source documents
- Advertisements (IRB approval needed)
- Participant folders
- Participant instructions
Study site initiation visit:
- Discuss protocol
- Review investigator's brochure
- Clarify protocol issues
- Review participant recruitment strategies and entry criteria
- Review drug dispensing, accountability, and storage
- Review case report forms and source documents
- Review adverse event reporting
- Review lab procedures
- Discuss oversight of the study by the lead organization for all participating organizations
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