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How to fill out the Site Initiation Visit Report online
The Site Initiation Visit Report is an essential document in the management of clinical investigations. This guide aims to provide clear and detailed instructions on how to effectively complete this report online, ensuring that all required information is accurately captured.
Follow the steps to complete the Site Initiation Visit Report online.
- Press the 'Get Form' button to access the Site Initiation Visit Report and open it in your preferred online editor.
- Begin by filling out the study title, investigator name, sponsor, and CIP number at the top of the form.
- Enter the monitor’s name and the date of the site initiation visit, as well as the expected start date for recruitment.
- Input the center number along with the principal investigator's name and address.
- List the site personnel present during the visit to ensure a record of attendance.
- Proceed to complete the sections under 'Background and Purpose of the Clinical Investigation', marking 'Y', 'N', or 'N/A' for each item and providing comments when necessary.
- Continue filling out the 'Study Procedures' section, verifying each item discussed and documenting any corrective actions.
- Move to the 'Clinical Investigation Plan Initiation and Enrollment' section, ensuring all participants and processes are accounted for.
- Document roles and responsibilities in the 'Staff Roles and Responsibilities' section while providing any necessary comments.
- Complete the 'SAE/SADE/USADE Reporting' and 'Data Collection' sections as per the format, ensuring accurate representation of procedures and forms.
- Fill out the 'Source Documentation' and 'Database Management' sections, verifying the necessary items and discussing their relevance.
- Complete the 'Regulatory Documentation', 'Review of Regulatory Documentation', and 'Ethics Committee Reporting Requirements' sections as applicable.
- In the final sections, address 'Record Keeping Requirements', 'Laboratory Procedures', 'Medical Device Allocation', 'Communication', and 'Site Monitoring'.
- Indicate any action items identified and add additional comments or general impressions in the designated sections.
- Finally, review the form for accuracy, save any changes, and download, print, or share the document as needed.
Complete your Site Initiation Visit Report online today.
The FDA pointed out two main reasons for Phase 3 failures (among others): Use of biomarkers in Phase 2 that did not accurately predict the Phase 3 outcome (e.g., oncology and cardiovascular disease) Untested mechanism of action.
Fill Site Initiation Visit Report
This template is a step-by-step checklist with convenient drop-down lists. To document that study procedures have been reviewed with the trial site and to document that they are ready to start the study. 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. Yes. The site has adequate space to accommodate the study. • Site Monitoring Visit Report will be provided highlighting any issues. • A copy of the monitoring report is filed in the e-ISF. The site initiation visit (SIV). Makes participating study sites ready for study conduct. Dit document gaat over de site initiatie visite waarvoor het team een template heeft opgesteld voor het site initiation visite rapport.
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