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Research Management Manual

Published by EATRIS

Translational ResearchResearch and Drug Development

The EATRIS Research Management Manual provides general guidance on how to structure and run a translational research project, from project initiation to project closure, to optimize the translational feasibility of your project.  It also provides the necessary tools and templates, based on best practice experience and established project management methodologies. 

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Advisory Committee for Therapeutics (ACT) toolkit – Report to applicant template

Published by UNEW

Translational ResearchResearch and Drug DevelopmentTREAT-NMDClinical DevelopmentClinical Trial DesignPreclinical ResearchTemplatesAdvice

After the review meeting, the lead reviewer, with input from the review panel, will create a report to the applicant which will include recommendations, advice and answers to the applicant’s specific questions. The lead reviewer will send the report to the secretariat to be formatted, reviewed and added to the report template before being sent out to the applicant.

This report to the applicant template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit. 

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Advisory Committee for Therapeutics (ACT) toolkit – Pre-application form template

Published by UNEW

Translational ResearchResearch and Drug DevelopmentTREAT-NMDClinical DevelopmentClinical Trial DesignPreclinical ResearchTemplatesAdvice

The pre-application form should be issued to potential applicants when they enquire about an ACT review. This form is designed to gain more information about their intended drug development plan and to allow the ACT Chair and secretariat to decide if their application is at a suitable stage for review. If accepted, this form will also be used by the secretariat to identify potential reviewers.

This report to the applicant template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit. 

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Advisory Committee for Therapeutics (ACT) toolkit – Conflict of interest (CoI) form template

Published by UNEW

Translational ResearchResearch and Drug DevelopmentTREAT-NMDClinical DevelopmentClinical Trial DesignPreclinical ResearchTemplatesAdvice

To ensure that a review panel includes independent and objective reviewers, each reviewer is required to complete a conflict of interest form for each application they review. The conflict of interest form must be submitted when a reviewer agrees to provide advice at a particular ACT meeting. Each form will be reviewed by the secretariat, in consultation with the ACT Chair. If a conflict of interest is identified for a specific application, they will not be able to review the application form or provide advice on the application.

This conflict of interest form template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit. 

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Advisory Committee for Therapeutics (ACT) toolkit – Applicant agreement template

Published by UNEW

Translational ResearchResearch and Drug DevelopmentTREAT-NMDClinical DevelopmentClinical Trial DesignPreclinical ResearchTemplatesAdvice

Once the pre-application form has been accepted for review, an applicant agreement form should be issued to the applicant to ensure that they are committed to attending an ACT review meeting. The agreement will include a request for donation. Please note that this agreement is only to be completed by industry applicants. You may wish to create a modified version for academic applicants.

This applicant agreement template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit. 

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This template includes a suggested schedule of timings, based on the TACT model. This agenda is intended for reviewers, observers and the secretariat. A modified version should be created for each applicant informing them of timings of the review, venue and a list of reviewers on their review panel. The modified version for each applicant will not include information about other applicants.

This agenda template can be used in conjunction with the ACT toolkit. For further information, please see the ACT toolkit. 

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The Advisory Committee for Therapeutics (ACT) toolkit provides procedural advice and guidance to replicate the successful TREAT-NMD Advisory Committee for Therapeutics (TACT) model in other rare disease communities. An ACT can provide independent and objective advice to industry and academia, on a real-life therapeutic pathway of drug development programmes. An ACT review can help an applicant to position a candidate compound along a realistic and well-informed pathway to clinical trial and eventual registration. 

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This manual is a comprehensive resource for early drug discovery, providing guidelines for developing therapeutic hypotheses, validating targets and pathways, and establishing proof of concept criteria. It includes analyses of costs at various stages of drug development. The content encompasses critical decision-making points in New Chemical Entity (NCE) development, exploratory Investigational New Drug (IND) processes, and orphan drug designation. Furthermore, it delves into Drug Repurposing and drug delivery technologies, making it an invaluable guide for professionals initiating new drug discovery and development programs.

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Japan Agency for Medical Research and Development (AMED) leads the Initiative on Rare and Undiagnosed Diseases (IRUD) program. The program provides patients across Japan suffering from undiagnosed diseases with a diagnostic strategy that involves genetic analysis

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