Keyword Analysis & Research: investigator site file index

hsa.gov.sg

https://www.hsa.gov.sg/docs/default-source/hprg-io-ctb/template-forms/investigator_site_file_contents_page_5feb2021.docx

Author: Sachidanandan SUMITRA (HSA) Last modified by: Limei CHONG (HSA) Created Date: 02/26/2021 00:39:00 Title: INVESTIGATOR SITE FILE-TABLE OF CONTENTS

Author: Sachidanandan SUMITRA (HSA)

Last modified by: Limei CHONG (HSA)

Created Date: 02/26/2021 00:39:00

Title: INVESTIGATOR SITE FILE-TABLE OF CONTENTS

DA: 90 PA: 73 MOZ Rank: 76

ucl.ac.uk

http://www.ctc.ucl.ac.uk/TrialDocuments/Uploaded/ANIMATE%20Investigator%20Site%20File%20Index%20v1%2022.10.2018_19112020_0.pdf

Investigator Site File Index Version 7.0 27/02/2018 Guidance Notes for Site Staff Investigator Site File (ISF) There should be one ‘central’ physical Investigator Site File (ISF) at site. Please ensure that the listed documents are kept within the ISF. The ISF must be stored in a secure location with restricted access. File Size: 188KB Page Count: 5

File Size: 188KB

Page Count: 5

DA: 58 PA: 89 MOZ Rank: 71

docest.com

https://docest.com/trial-master-file-investigator-site-file-index

This Trial Master File/ Investigator Site file index template has been produced with regards to the documentation required by UHL, as Sponsor, for the completion of both single and multi-centre CTIMP studies. This Index can be modified to suit individual study requirements. The documentation detailed in bold is for individual Site, Investigator Site Files.

DA: 19 PA: 4 MOZ Rank: 87

clinicalresearchinfo.com

https://clinicalresearchinfo.com/what-is-investigator-site-file-isf/

Nov 20, 2020 · The investigator site file is consists of trial documents from the initiation to closeout. Maintaining the site file is the responsibility of principal investigators. Principal investigators are doctors or any medical practitioner for a particular disease or indication. Principal Investigators have many responsibilities.

DA: 45 PA: 49 MOZ Rank: 12

hsa.gov.sg

https://www.hsa.gov.sg/clinical-trials/conducting/investigator-site-file

An Investigator Site File (ISF) should be established at the beginning of each clinical trial. The ISF contains the minimum list of essential documents that have to be maintained throughout the clinical trial. Refer to Section 8 of the ICH E6 (R2) Good Clinical Practice for further guidance. Refer to our ISF Content Page template for more details.

DA: 27 PA: 87 MOZ Rank: 65

complion.com

https://complion.com/what-goes-into-an-investigator-site-file/

Oct 26, 2021 · The investigator site file (ISF) plays a critical role in a study’s success. But only if the people in charge of it – clinical trial investigators – keep its contents accurate and up to date. In this post, we provide an overview of all essential documentation in an effective, compliant ISF. Investigators have a few responsibilities. They control the drugs under investigation.

DA: 34 PA: 79 MOZ Rank: 40

novotech-cro.com

https://novotech-cro.com/faq/what-investigator-site-file-isf

An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines. According to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, essential documents are defined as “documents which individually and collectively …

DA: 56 PA: 37 MOZ Rank: 70

icnarc.org

https://www.icnarc.org/Our-Research/Studies/Current-Studies/Pressure/Information-For-Sites/Investigator-Site-File

The Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements, from initiation to closeout. Current ISF version The new ISF (v5.0) for PRESSURE will be available here soon. Previous ISF versions. PRESSURE ISF (v4.0) PRESSURE ISF (v3.0) PRESSURE ISF (V2.1)

DA: 77 PA: 54 MOZ Rank: 49

docest.com

https://docest.com/investigator-site-file-table-of-contents

INVESTIGATOR SITE FILE. Protocol Number / : Site Number / : Principal Investigator / : SECTION / DOCUMENTATION / PRESENT / COMMENT. 1 / Contact Details. 1.1 / Contact list of studypersonnel / ☐ /. 2 / Investigator’s Brochure/ Product Information. 2.1 / Current Version / ☐ /.

DA: 26 PA: 71 MOZ Rank: 10