What is a site initiation visit?
A Site Initiation Visit (SIV) or Study Start-Up is an organized meeting to discuss the new protocol before the research project is ready to screen and enroll potential patients. It also serves as training for the protocol of interest.
What are some key forms completed at the site initiation visit?
All essential documents such as case report forms (CRFs), informed consent forms, etc. Monitoring. Adverse Event/Adverse Device Effect Reporting. Data collection and record keeping.
How do I prepare for a website initiation visit?
The following pre-requisites should be completed prior to the site initiation visit: protocol and consent have been reviewed and approved by any required Scientific Review, the DSMB, and the IRB; the case report form and data collection system have been finalized; the Manual of Procedures (or set of study specific …
Who attends the site initiation visit?
All study staff responsible for the implementation of the study will attend the initiation visit. This typically includes the PI, co-investigator(s), study coordinator, research nurses, and/or other study staff who will interact with participants, as well as data management staff.
What does SIV mean in clinical trials?
Site Initiation Visit
Site Initiation Visit (SIV) The on-site meeting designed to prepare the study team for conducting the study. The meeting includes (at a minimum) the PI, other investigators, site study coordinator, other site staff assuming study responsibilities, and data management representative.
What is site feasibility visit?
Site feasibility is the process of evaluating the possibility of conducting a clinical trial or study, at a particular site. The process aims at ensuring that the proposed clinical site can conduct the trial, within the budget and the timeline, whilst maintaining data integrity and participant safety.
At which study visits can the site expect?
At which study visits can the site expect the sponsor to review subjects’ signed informed consent forms? Periodic and termination site visits. The subject informed consent forms are reviewed at the periodic site visits and the termination site visit.
How long does a site initiation visit last?
about 7 hours
The length of an initiation visit may vary according to the complexity of each study, but a typical initiation visit lasts about 7 hours.
What is a PI in clinical research?
The person(s) in charge of a clinical trial or a scientific research grant. The PI prepares and carries out the clinical trial protocol (plan for the study) or research paid for by the grant. The PI also analyzes the data and reports the results of the trial or grant research. Also called principal investigator.
How long does a site initiation visit take?
How long does the initiation visit last? The length of an initiation visit may vary according to the complexity of each study, but a typical initiation visit lasts about 7 hours. Not all parts of the visit require attendance by all staff.
What are the essential documents?
Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.