What is a non-substantial amendment?

What is a non-substantial amendment?

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

Do non-substantial amendments need Rec approval?

Non-substantial amendments should be notified to the Sponsor where they may affect indemnity. However, they do not need REC, HRA or MHRA approval. Records of the amendment and when it was implemented must be kept in the Research File (Trial Master File for Clinical Trials).

What is conep in Brazil?

Overview. The National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) is the central statutory body responsible for the registration, audit, and accreditation of institutional ethics committees (ECs), known as Committees of Ethics in Research (Comitês de Ética em Pesquisas (CEPs)) in Brazil …

What constitutes a substantial protocol amendment?

Amendments to the trial are regarded as “substantial” where they are likely to have a significant impact on: the safety or physical or mental integrity of the subjects, or the scientific value of the trial, or the conduct or management of the trial, or the quality or safety of any IMP used in the trial.

Who decides if an amendment is substantial or not?

It is the sponsor’s responsibility to decide whether an amendment is substantial or non-substantial.

What are the 3 categories of amendments?

Constitutional amendments can be divided into the Bill of Rights, Civil War amendments, and 20th century amendments.

What is anvisa in Brazil?

The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the Brazilian Health Regulatory System (SNVS), present throughout the national territory.

Is adding a site a substantial amendment?

For CTIMPs conducted at NHS/HSC sites, the addition of a new site and/or addition or change of a Principal Investigator, is no longer considered a substantial amendment.

What is the Article 368?

Part-xx Article 368 (1) of the Constitution of India grants constituent power to make formal amendments and empowers Parliament to amend the Constitution by way of addition, variation or repeal of any provision according to the procedure laid down therein, which is different from the procedure for ordinary legislation.

What is full form ANVISA?

The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others.

Who approves drugs in Brazil?

As delineated in ResNo61, ANVISA oversees five (5) directorates including the Sanitary Authorization and Registration Board, the directorate responsible for granting approval to conduct clinical trials for drugs to be registered in Brazil.

What’s the difference between substantial and non-substantial amendments?

Substantial & non-substantial amendments. Amendments are changes made to the research after a favourable ethical opinion has been given. They can be ‘substantial’ or ‘non-substantial’.

What is an amendment to an ethical opinion?

Amendments are changes made to the research after a favourable ethical opinion has been given. They can be ‘substantial’ or ‘non-substantial’. A substantial amendment is defined as an amendment to the terms of the application, or to the protocol or any other supporting documentation, that is likely to affect to a significant degree:

Do you need to inform NHS REC of non-substantial amendments?

You must inform the main NHS REC of all substantial amendments by completing a notice of substantial amendment. Non-substantial amendments do not need to be notified. For further details please see NHS HRA: UK Process for Management of Amendments.

Can a Safety Amendment be implemented without ethics approval?

There is an exception to this rule. Where an amendment is an urgent safety amendment this can be implemented without receiving approval from ethics or the appropriate regulatory body. The second type of amendment is the non-substantial or minor amendment which does not need to be approved prior to implementation.