Who attends the site initiation visit?

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 is SIV in clinical research?

The site initiation visit (SIV) is a critical activity completed by the Sponsor prior to the start of a study.

What does site initiation mean?

Site initiation is the process by which the sponsor is assured that the Principal Investigator (as delegated via agreement) is sufficiently trained in the following protocol, understands the instructions and the site is ready to commence the study.

What is visit in clinical trials?

Pre-study visits (site selection visits or site qualification visits (SQVs)) are conducted to determine if the investigator and clinical site have the capability to conduct the study. During this visit, both an investigator and a study coordinator must be available.

What is a dry site initiation visit in clinical trial?

An SIV or Site Initiation Visit is a monitoring visit that takes place after the Site Selection Visit. It is a visit that happens after the study sponsor has already selected the site for participating in a clinical trial.

What is a site activation visit?

Site activation refers to how many trials were able to get off the ground and enroll-or have the capacity to enroll-at least one patient.

How do you conduct a site initiation visit?

When conducting the site initiation visit (SIV):

1. Review the protocol in detail.
2. Review instruction on any specialised procedures such as diagnostic tests and special computer programs.
3. Receive direction for Case Report Form (CRF)/electronic CRF completion & safety reporting.
4. Define source documents.

What is an investigator meeting?

An Investigator Meeting is a time for everyone involved with a new clinical trial to meet face to face and get familiar with the study, including learning about the roles in the study.

How do you end a clinical site visit?

A close out visit should ensure that all outstanding Case Report Forms (CRF’s) have been corrected, collected, organized, and filed as required. All data needs to be clean and complete with queries all being corrected and resolved as well as signed off by the Principal Investigator (PI).

When can the clinical trial close out visit be done?

A final trial close-out can only be done, once all sites have been closed and the Project Manager and/or monitor has reviewed both, the ISF and TMF, and confirmed that all necessary documents are in their appropriate files. The database is locked, once all queries have been resolved, and the data is ready for analysis.

What is the purpose of a site initiation visit?

The DRIVE Project Top Tips: Site Initiation Visit Delivery of Research Improvements Meeting purpose: The purpose of a Site Initiation Visit (SIV) is to prepare and set up a research site to conduct a study.

Who is responsible for the study initiation visit?

The visit is usually conducted by the trial coordinator or often a monitor on behalf of the sponsor. Essentially their aim will be to work with the sites to ensure that the site’s planned operational procedures fits with the requirements of the protocol and will ensure accurate data as well as safe and ethical conduct of the trial.

What should be covered during an initiation visit?

Where this occurs, it should be made clear and documented in the study files what training has occurred to replace the initiation visit. – A site checklist is used by the monitor or trial coordinator to ensure that all items have been covered during the initiation visit.

Can You retrieve documents from an initiation visit?

It is possible to retrieve the last of the documents at the initiation visit provided the site has confirmed that they have these documents at site for collection. – All trial staff should also be available at the visit.