What is the Nonclinical Common Report Template?BioCelerate is developing a nonclinical report template as a companion to the currently available V1.0 Nonclinical Common Protocol Template for the purpose of supporting consistency and efficiencies in the report generation process and reduce the burden on sites, CROs, and sponsors.
Guiding Principles for the Nonclinical Common Report Template
The goal of this NCRT is to:
- Reduce cycle times
- Simplify the report generation process for study directors at both Sponsor and CRO organizations
- Reduce quality assurance/quality control using hyperlinks to contributor reports
- Facilitate Regulatory review by having information presented in the same order and format
How to Get Involved
The Nonclinical Common Report Template V1.0, along with background and implementation materials (see links below), is now available for use. This companion document to BioCelerate’s Nonclinical Common Protocol Template is based on the structure of the NCPT and stakeholder feedback. We invite you to review the Template and Implementation materials and to share your feedback. Feedback will continue to be key to robust and well-accepted Templates.
We invite all stakeholders to submit feedback using the form below or you may also provide more detailed, section-specific feedback offline by downloading the detailed feedback Excel spreadsheet and emailing the completed form to email@example.com. We take your feedback seriously and greatly appreciate any and all responses.
|V1.0 Nonclinical Common Report Template||A nonclinical report template for repeat-dose toxicology studies|
|Why Common Templates? Initiative Overview||Provides an overview and background of the nonclinical common protocol template project|
|Approaches to Implementation||A resource to support an organization’s efforts in determining if and how the organization will adopt the nonclinical protocol template|
|NCT FAQs||Answers to Frequently Asked Questions regarding the nonclinical protocol template|
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Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations. All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.