Elements for clinical trial standards for NABH

1. NABH standards in clincal trial

2. NABH draft accreditation standard and accreditation process
The draft accreditation standards for clinical trial were issued by
National Accreditation Board for Hospitals and Healthcare
Providers (NABH) in January 2015.
The accreditation standard released by NABH has been classified
into three sections, which have further been divided into
standards and their respective objective elements.

3. Accreditation of the ethics committee
EC composition, procedures for new induction and resignation of
members,
Frequency of ethics committee meetings, receipt, review and
decision making of proposals,
Review of protocol amendments,
Procedure for deliberations and maintaining minutes,
Periodic review and oversight,
Procedure to be followed for vulnerable population,
Review of informed consent document and informed consent
process etc.

4. Ethics Committee
• Total number of actions (e.g., new studies, continuing reviews,
modifications, exemptions etc.).
• Time from board meeting to approval of minutes by the chair (target =
90% ≤ 4 days).
• Member attendance (target = at least 10 of 12 meetings/year).
• Member reviewer comments submitted prior to meetings (target = 90%
within 2 days of meetings).
• Informed consent document readability using the Flesch-Kincaid
Instrument (target = reading ease ≥45 or grade level ≤eighth).
• For new protocols, the mean number of days from submission to review at
meeting*.

5. Ethics Committee
• For new protocols, the mean number of days from submission to approval*.
• For new protocols reviewed using the expedited procedure, the mean
number of days from submission to review*.
• For new protocols reviewed using the expedited procedure, the mean
number of days from submission to approval*.
• Set up a process to identifying goals for these measures.
• Basic descriptive analysis of the data on a monthly basis using a spreadsheet
program. This will include the monitoring.

6. Accreditation of the investigators
Investigator’s role and responsibilities;
Investigator’s education, qualification and experience;
Investigators to follow site SOPs (standard operating procedures)
A study protocol for all essential trial activities and if there is a
contradiction,
Study protocol requirements would take a upper hand.

7. Monitoring for Principal Investigator
Identifying high-risk trials and conducting an end to
end monitoring of compliance to:
Adherence to protocol.
Consent process.
Data capture.
Drug accountability.

8. Monitoring for Principal Investigator
Study Preparation
Patient Safety
Study Conduct
Starting the study
Enrolling patients

9. Clinical Study Investigator.

Be qualified to practice medicine or psychiatry and meet the
qualifications specified by applicable national regulatory
requirements(s) Be qualified by education, training, and
experience to assume responsibility for the proper conduct of the
study.

Be familiar with and compliant with Good Clinical Practice
(GCP) ICH E6 Guideline and applicable ethical and regulatory
requirements prior to commencement of work on the study.

Provide evidence of his/her qualification using the Abbreviated
Curriculum Vitae (CV) form

10. Accreditation of clinical trial sites
Subject protection policy,
Informed consent,
Including procedures for audio-visual recording of consent,
Medical management of adverse events,
Adverse events and serious adverse events reporting (including
emergency care),
Roles and responsibilities of the study team,
site research team training; research pharmacy (investigational
product management),
Protocol compliance and protocol deviations etc.

11. Accreditation of clinical trial sites
Subject protection policy,
Informed consent,
Including procedures for audio-visual recording of consent,
Medical management of adverse events,
Adverse events and serious adverse events reporting (including
emergency care),
Roles and responsibilities of the study team,
site research team training; research pharmacy (investigational
product management),
Protocol compliance and protocol deviations etc.

12. Role of an Institution/Organization
Organization can conduct audits or surveys or uses other methods to
assess compliance with organizational policies and procedures;
and applicable laws, regulations, codes, and guidance.
The organization makes improvements to increase compliance when
necessary. Organization ensures that compliance to adherence to
rules and regulations is maintained by regular assessment of
measures of compliance with important indicators.
The data, in order to measure compliance, will be analyzed and
based on the analysis, corrective action can be taken to improve
compliance.
E.g., compliance to consent process.