NABH standards in clincal trial

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.

Accreditation of the ethics committeeEC 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.

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*.

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.

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.

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.

Monitoring for Principal Investigator

Study Preparation

Patient Safety

Study Conduct

Starting the study

Enrolling patients

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

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 .

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 .

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.