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AccreditationProcess ClinicalTrial

The document outlines the process for NABH accreditation of Ethics Committees. It involves an Ethics Committee applying with relevant documents and fees. NABH reviews the documents within timelines and may provide feedback. An on-site assessment is then conducted, followed by an accreditation committee review. Accreditation is recommended or denied, and is valid for three years with surveillance assessments in years 1 and 2. Provisional accreditation for up to 12 months is also possible pending trial approval processes.

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24 views2 pages

AccreditationProcess ClinicalTrial

The document outlines the process for NABH accreditation of Ethics Committees. It involves an Ethics Committee applying with relevant documents and fees. NABH reviews the documents within timelines and may provide feedback. An on-site assessment is then conducted, followed by an accreditation committee review. Accreditation is recommended or denied, and is valid for three years with surveillance assessments in years 1 and 2. Provisional accreditation for up to 12 months is also possible pending trial approval processes.

Uploaded by

shahidashraft
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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National Accreditation Board for Hospitals and Healthcare Providers (NABH), Quality Council of India

has developed a system of accreditation for Ethics Committees (EC). Accreditation shall be granted
as per details and scope provided in the application form.

Process of NABH accreditation

Ethics Committee applies to NABH in prescribed application form (common form) along with self-assessment
toolkit, relevant documents and application fee.

Within 10 days of receipt of application

Application form is screened at NABH secretariat and an acknowledgement letter is issued to the ethics committee
along with the unique reference number

Within 30 days of receipt of application

Self-assessment toolkit and other documents submitted by the ethics committee are reviewed and the feedback is
shared with the applicant

Within 60 days of receipt of application

Onsite assessment is planned upon receiving corrected documents, if any and payment of accreditation fee

On site assessment conducted. Copy of the report provided to the ethics committee

Within 2 months of on-site assessment

Submission of corrective actions, if any by the ethics committee

Accreditation Committee

New ethics committee Registered ethics committee

Accreditation recommended or denied. Approval by the Board.


Accreditation cycle: three years.

Provisional Accreditation: NABH would grant provisional accreditation in situations wherein ethics committee has
not initiated reviewing, monitoring & approving trials but qualify for accreditation based on documentation and on-site
assessment by NABH assessment team. Such accreditation if granted, will be valid for a maximum of 12 months and
ethics committees must initiate trial approval process after taking prior permission from the competent authority within
this period failing which accreditation will be withdrawn and ethics committee shall have to apply afresh.

During the provisional accreditation, ethics committee shall keep NABH informed on contracting with a sponsor,
approving & monitoring first trial including sites & Investigators. So NABH can accordingly arrange a visit to ethics
committee for verification of implementation of standards at an appropriate time.

Based on the assessment report, the accreditation committee may either recommend for continuation of accreditation or
withdrawal of provisional accreditation.
After Accreditation

Surveillance onsite assessment between fifteen to eighteen


months from the date of accreditation. Second year fee
payment

Submission of the closures of the non-conformities by the


accredited entity

Review of the closures by NABH secretariat and the


assessment team

Review of the assessment report and closures by the


accreditation committee and recommendation of the
continuation of accreditation or adverse decision

Submission of third year


annual accreditation fee

Accredited entity applies to NABH secretariat 6 months


before expiry of accreditation for renewal along with the
renewal application, fee and relevant documents

Further process remains same as for new application


except generating reference number.

In addition to the regular surveillance assessment, NABH may call for an un-announced visit, which could
be a Surprise Assessment or based on any concern/ complaint/ feedback reported by any individual or
organization or media.

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