The structure and format of applications to be submitted to regulatory authorities in the USA, Europe, and Japan has been defined within the International Conference on Harmonisation (ICH).

Common Technical Document

The CTD describes the organization of modules, sections and documents to be used by applicants for marketing authorizations , according to the ICH of Technical Requirements for Registration of Pharmaceuticals for Human Use.

The Common Technical Document is composed of five modules:

 

 

  • Administrative and prescribing information (regional module)

  • Overview and summary of modules 3 to 5

  • Quality (pharmaceutical documentation)

  • Nonclinical (Pharmacology/Toxicology)

  • Clinical – efficacy (Clinical Trials)

Electronic Common Technical Document – eCTD

The eCTD is an interface for industry-to-agency transfers of regulatory information while at the same time facilitating the creation, review, lifecycle management and archival of electronic submissions.

Latest Glossary Definitions

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.

The plan describes the reference policies and procedures to follow.

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.

Protection of personal data (PPD)

In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Lay person summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

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