Use Networking to create a Database of Potential Investigative Sites. Identify potential IRB/IEC. Select investigators appropriate for the therapeutic area and protocol
Create a draft Research Site Evaluation Form. Do not submit the letter to potential investigators. The senior researcher of your group must review the document.
Develop Study time lines. Create a draft of detailed plan of the study.
Compose a draft checklist for Site Initiation
Create a draft of checklist for Monitoring Site Visit
Create a draft of an appropriate CRF (case report forms)
Create a checklist for site close out.
Prepare schedule of events and description of procedures
Perform protocol review
Prepare site contract (investigator/site agreement).
Draft and review the informed consent
Develop subject tracking system
Prepare randomization schedule(s) for blinded studies
Prepare samples of packaging, labels and order forms for the investigational product. NOTE: the purpose of this task is to ensure that the correct/appropriate information is contained in these items and that these meet regulatory standards...you do not need to ACTUALLY make a package or label!
Prestudy Visit (after the sponsor is found) Prepare documents necessary to proceed with prestudy (site selection) visit (e.g., confidentiality agreement, curriculum vitae)
Prepare documents necessary for prestudy visit to the site: Investigator's Brochure
How will you assess investigator/study staff?
Plan multicenter investigator's meeting(s)
Prepare the investigators' meeting report form
Prepare the study initiation visit report form.
Prepare the study monitoring visit report form.
How will you ensure adequacy of study supplies at a site and ensure adequacy of investigational product at a site?
How will you monitor and evaluate subject enrollment? Create appropriate forms.
Create a checklist to conduct a monitoring visit and include the following: assess protocol adherence to ensure that critical studies are conducted in accordance with local, state, federal, and appropriate regulatory regulations (e.g., IRB/IEC approval, informed consent, laboratory certification);
Ensure that informed consent process is conducted according to Good Clinical Practice (GCP);
Identify and communicate subject safety issues to appropriate staff (e.g., laboratory abnormalities);
Check collection and storage of biological samples; arrange for shipment of biological samples;
Assure proper investigational product storage, handling, disposition, and accountability documentation;
Reconcile investigational product accountability; ensure that protocol amendments have been reviewed, approved, and implemented; review study files and regulatory documents at site for completeness and accuracy (e.g., FDA form 1572 , sponsor/CRO correspondence, informed consent form);
Review CRFs and source documents for completeness and consistency; identify and report significant adverse events to appropriate staff; confirm subjects' investigational product compliance;
Identify study site deficiencies; provide continuing training, and implement corrective action when necessary; sign and date site monitoring visit log; review lists of subjects screened at site (i.e., screening log); assess enrollment issues.
Prepare the monitoring visit follow-up letter to the site
How will you identify potential fraud and misconduct? Create appropriate checklists and forms.
Create report form for significant adverse events
How will you participate in SAE reporting activities?