What is a trial initiation visit?
Why do we do initiation visits?
Who conducts a trial visit?
Which is the main purpose of an 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 happens after site initiation visit?
Once the site is initiated, it is important that the research team notifies all parties involved in the study. Internal supporting ancillary departments may require subsequent kick-off meetings to discuss study logistics.
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 do site initiation visits typically include?
Other topics of discussion during the site initiation visit include: Study overview, eligibility criteria, procedures, access to suitable patient population. Lab manual, requirements for research sample processing and shipping.
What will you do in preparation for the site initiation visit?
Preparing for the Initiation Visit - The monitor should check that all regulatory documents have been retrieved prior to the meeting. 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.
What is a dry site initiation visit?
It is a visit that happens after the study sponsor has already selected the site for participating in a clinical trial. During the SIV, the CRA (Clinical Research Associate) will make sure that the site is ready to actually start enrolling subjects in the clinical trial.
What is the purpose of a site meeting and who are the persons that would attend?
Site meetings are an important part of the successful management of construction projects. Regular site meetings between the different stakeholders on a project can help facilitate better communication and a shared sense of purpose making it more likely that the project is completed successfully.
What does FPI mean in clinical trials?
first patient enrolledThe achievement of the first patient enrolled (FPI) into a clinical trial is one of the most highly anticipated events of the clinical development process. The pressure to reach this milestone, whether to meet a corporate target or outpace the competition, is intense.
What is site visit in construction?
Site visits in construction education are learning experiences that aid the students to better understand real-world construction practices. These field trips create a guided interactive environment for students, enabling awareness of spatiotemporal challenges present in a construction project.
Is a site initiation visit mandatory?
The Site Initiation Visit (SIV) is required to prepare and set up a research site to conduct a study and must occur prior to patient recruitment. The principal investigator (PI) must attend this visit together with as many members of the research team as possible.
What is a site evaluation visit?
A Site Evaluation Visit (SEV) is conducted by the Sponsor or CRO to evaluate a Site's and Investigator's resources and capabilities to conduct a study. This type of visit is also referred to as an SSV (Site Selection Visit) or SQV (Site Qualification Visit).
Who is responsible for conducting site visits in clinical trials?
A qualified investigator is: responsible for conducting the clinical trial at the clinical trial site on behalf of the sponsor.
What are some key forms completed at the site 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 ...
What happens after clinical trials are completed?
What happens after a clinical trial is completed? After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing.
What does FPI mean in clinical trials?
first patient enrolledThe achievement of the first patient enrolled (FPI) into a clinical trial is one of the most highly anticipated events of the clinical development process. The pressure to reach this milestone, whether to meet a corporate target or outpace the competition, is intense.
What is a pre study site visit?
The purpose of a pre-study visit is for the study sponsor to assess whether or not Beaumont will be an adequate site, including evaluation of the facilities, investigator(s) and study staff qualifications and experience, and the potential clinical population from which subjects will be recruited and enrolled.
SITE INITIATION VISIT FORM/ Checklist - Elsmar
The purpose of this document is to provide the Lead Site with a system for performing study initiation visits. Instructions: The following items should be addressed when initiating a participating site into a multi-center trial.
Site Initiation Visit Agenda Template
Summary Sheet. Title: Site Initiation Visit Agenda Template Purpose: This template may be used as a starting point for planning a site initiation visit meeting.
Site Initiation Visit Agenda Template - National Institute of Dental ...
Title: Site Initiation Visit Agenda Template Subject: Tool Summary Sheet Author: NIDCR Keywords: site, initiation, data, source, documentation, accountability
Site Initiation Checklist
For studies NOT involving Investigational Medicinal Products or Devices (i.e., Non-CTIMP studies) Page 1 of 6 SOP S-1011 Appendix 7 Non-CTIMP Site Initiation Checklist & Outstanding Issues Report v1.1 Sept 2021
Guideline: Study Start-up to SIV and Site Activation
A controlled study involving human subjects, designed to test a well-characterized behavioral intervention and evaluate prospectively the efficacy or effectiveness of the behavioral or psychosocial intervention on behavioral or social targets relevant to public health.
What
Prior to study enrollment, the study monitor on behalf of the sponsor will conduct a Site Initiation Visit (SIV) to provide the principal investigator and the study team training on the protocol, procedures, processes and monitoring plan. The monitor will also review the responsibilities of the investigator ( 21 CFR 312 Subpart D ).
When
The SIV typically occurs once the site has completed their regulatory requirements (upon IRB approval and contract execution).
Clinical Research Unit (CRU)
If you are utilizing the services of the Clinical Research Unit (CRU) for your study, an in-service meeting with the CRU team may be required prior to scheduling services. At the in-service, the study protocol and procedures will be discussed to ensure that all of the elements are in place to safely and effectively begin the study.
BioMedical Engineering and Imaging Institute (BMEII)
Depending on the complexity of the study, a kick-off meeting may be required prior to the start of the study to review the workflow with all related parties.
Investigational Drug Service (IDS)
Investigator Initiated studies that are using the Investigational Drug Service (IDS) are required to schedule a kick-off meeting prior to enrolling subject. Topics to be discussed include institutional logistics, training, IDS workflow.
When is an NCCIH initiation visit scheduled?
An NCCIH initiation visit occurs once the final protocol, CRFs, ICF, and DSMP are approved by NCCIH and the local IRB, and before any participants are enrolled in the study.
Who schedules the initiation visit?
With NCCIH approval, a monitor (sometimes referred to as a clinical research associate or CRA) will contact the PI or study coordinator by phone or email to begin scheduling a visit. The monitor will inquire about availability and scheduling preferences, providing as much notice as possible.
What arrangements need to be made for the initiation visit?
The monitor will ask the site staff to reserve an appropriate meeting space for the visit. This request may also include equipment, such as a projector, screen , and/or conference phone line.
What study documents will the monitor review during the initiation visit?
The monitor will review the following NCCIH- and IRB- approved documents, as applicable to the study:
What topics will be discussed during the initiation visit?
The monitor will provide the site with a draft initiation visit agenda in advance of the visit, and will work with the PI, study coordinator, or other designee to finalize the agenda prior to the visit. The initiation visit agenda will include the following items, with modifications to reflect the specifics of each protocol and study team:
Will any followup be required after the initiation visit?
The monitor’s written report will outline any Action Items that require followup, and the Action Items will also be listed in an Action Item – Site Response Form. The site will have 30 days after receipt of the monitoring report to respond to the Action Items identified in the report. The response to the Action Items should be submitted in writing to the monitor.
How will I know when the study may open to enrollment?
The study may open to enrollment upon receipt of written approval from the NCCIH program officer. Before NCCIH approval is granted, the site must show that all Action Items from the initiation visit have been resolved or there is an adequate plan for resolution in place.
Dan Sfera Follow
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.
Vaibhav Nikam
Hi prashant, As you are the CRA , can you please give me brief idea of initiation of clinical trial site in india.
Thomas Wilson
I would add too that the CRA should ideally give some kind of presentation on the trial they plan to monitor.
What are the pre-requisites for a site 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 Standard Operating Procedures have been prepared); and all necessary site staff have been identified.
What is the order of agenda topics?
The order of agenda topics is a best practice recommendation. Irrespective of customization, it is recommended that protocol overview and MOP review remain together. It is also recommended that review of roles and responsibilities occur early in the meeting.
What is site initiation?
Site initiation visits occur prior to site activation for a specific protocol. These visits have several goals: to orient and train staff on the protocol and study related processes; to confirm readiness for study implementation; and to identify additional requirements that must be satisfied prior to site activation and subject recruitment.
What is a trial initiation visit?
A trial initiation visit is conducted prior to the first patient being recruited into a study. These meetings are important whether the trial is commercial, non-commercial or academic, and for any type of intervention. The visit is usually conducted by the trial coordinator or often a monitor on behalf of the sponsor.
Why do we do initiation visits?
An initiation visit is performed to ensure the investigators and study staff understand the study protocol, that all the operational steps are in place, and that everyone is clear and well trained in their specific roles and responsibilities. A trial initiation visit is conducted prior to the first patient being recruited into a study.
Who conducts a trial 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.
