MODULE G SIV Visit Presentation

download report

Transcript MODULE G SIV Visit Presentation

Jane Fendl
April 14, 2010
Version: Final 14-Apr-2010
Purpose of the visit
 Preparing for the visit
 Conducting the visit
 Source documents
 Contact information
 Writing the report
 Follow-up procedures & action items
Version: Final 14-Apr-2010
Purpose of an Site Initiation Visit
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
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
◦ 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
Version: Final 14-Apr-2010
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
Version: Final 14-Apr-2010
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
Ship any necessary documents or materials
so that they arrive at the site on time
Version: Final 14-Apr-2010
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
Version: Final 14-Apr-2010
Conducting the Visit
See separate SIV presentation slides
Version: Final 14-Apr-2010
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
Version: Final 14-Apr-2010
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
Receipt documentation is present
Blinding preserved
Meet with the Investigator to review any
outstanding issues and state if enrollment
can begin
Version: Final 14-Apr-2010
Writing the Report
Refer to SIV Report Template Handout
Version: Final 14-Apr-2010
Follow up Procedures & Action
Complete visit by writing a “Follow-up Visit”
letter to the Investigator
 Items to include:
◦ Thank the Investigator and staff for their
◦ 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