MODULE G SIV Visit Presentation
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Transcript MODULE G SIV Visit Presentation
MODULE G
INITIATION VISIT
Jane Fendl
April 14, 2010
Version: Final 14-Apr-2010
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AGENDA
Purpose of the visit
Preparing for the visit
Conducting the visit
Source documents
Contact information
Writing the report
Follow-up procedures & action items
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Purpose of an Site Initiation Visit
(SIV)
To review/train the Investigator and staff on
the protocol
To review/train the Investigator and staff on
all required protocol procedures
To review the roles and responsibilities of all
involved parties
To confirm that the Investigator, facilities and
staff are prepared to begin the study
Communicate sponsor standards and
expectations in regards to GCP
Final step before conducting the actual study
Version: Final 14-Apr-2010
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Preparing for the SIV
Review and confirm that all regulatory
documents are acceptable and in the
sponsor file
Schedule a date with the site to perform the
SIV
◦ Call to determine a date when the entire staff
can be present
Investigator, Sub-Investigators, Research fellows,
Specialists, Study coordinator, Study nurse, Pharmacist,
Laboratory Tech, Administrator
Inform the Project Manager of date
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Preparing for the SIV
Send a confirmation letter with agenda to
the Investigator
A few days before call the site to:
◦ Confirm that the site has received all
documents, study supplies
◦ Confirm that all administrative and logistical
arrangements are completed
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Preparing for the SIV
Gather documents and materials for the visit
Protocol and slide presentation
Samples of drug packaging
Samples of laboratory kits
Blank CRF
◦ Annotated CRF
◦ CRF completion guidelines
Logs
Ship any necessary documents or materials
so that they arrive at the site on time
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Conducting the Visit
Be prepared to document the visit by
taking notes or using SIV report form
Introduce your self, other sponsor staff
and have site staff introduce themselves
Attendance – have all the attendees sign a
training form
Be flexible with agenda – ask about staff
schedules and adjust if necessary
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Conducting the Visit
See separate SIV presentation slides
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Source Documents
The first place that study documentation
is recorded
◦ Lab reports, x-rays, ECG tracings, Progress
notes, electronic records
Review the Source Documents with the
Study Coordinator
◦ Complete the Source Document log
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Individual Contacts
Meet with anyone who could not be present
at the SIV meeting
Inspect facilities to assure no changes
occurred from the PSSV to the SIV
Inspect the Clinical Drug Supplies
◦
◦
◦
◦
Complete
Damage
Receipt documentation is present
Blinding preserved
Meet with the Investigator to review any
outstanding issues and state if enrollment
can begin
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Writing the Report
Refer to SIV Report Template Handout
Version: Final 14-Apr-2010
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Follow up Procedures & Action
Items
Complete visit by writing a “Follow-up Visit”
letter to the Investigator
Items to include:
◦ Thank the Investigator and staff for their
attendance
◦ Confirm they can begin enrolling if applicable
◦ List outstanding items
◦ Offer resolutions to outstanding items
◦ Provide a possible date of next visit
Version: Final 14-Apr-2010
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