search
Home
Catalog
Favorite
Log In
Profile
Added resources Add resource Favorite resources Collections Add сollection Personal Information Change password Log out

More results...

Log In
go back

EU-PEARL’s Suite of master protocol templates

⌂ > ⌂ > Research and development > clinical trials / studies > EU-PEARL’s Suite of master protocol templates
Life cycle of medicinal products and medical devices:
clinical trials / studies
Resource type:
library
Language:
[EN] English
Report
March 14, 2024
Description

Master templates of 5 clinical trial documents:

  • Master Protocol Template* (MPT) V4 25April2023
  • Intervention Specific Appendix* (ISA) template V4 25April2023
  • Statistical Analysis Plan^ (SAP) template V3 25April2023
  • Data Monitoring Committee (DMC) charter template V1 25April2023
  • Guidance for supplementary information to the CTR Cover Letter associated with the Master protocol and ISA submission V4 25April20235

The templates can be downloaded as MS Office documents.

Updated on March 29, 2024
Open resource
Comments

Leave a Reply

  1. Add to list add to your list
See also
SPOR – Referentials Management System by EMA

SPOR is a website that manages substance, product, organization, and referential master data. This service complies w...

0
add to your list
TranslaStars: online learning platform for language professionals

TranslaStars offers a broad selection of online courses for translators, interpreters, and localization project manag...

0
add to your list
DermNet

DermNet is an English-language dermatology encyclopedia. The website is designed for the general public, with additio...

0
add to your list
Saved current search
Add сollection