US FDA do not prohibit use of MS Excel for data management
Wednesday, April 05, 2017, 08:00 Hrs [IST]
What’s NABH process for accreditation of Ethics Committee (EC)?
Dr Maya RamakrishnanNABH has released an Information Brochure for Ethics Committee Accreditation Programme in December 2016.
Ethics Committee willing to be accredited by NABH must ensure the implementation of NABH standards. accreditation of Ethics committee has 10 standards and 49 objective elements.
The standards encompass the following:
The Ethics Committee should make an application to NABH by sending
- Authority for formation of Ethics Committee
- Standard Operating Procedures (SOPs)
- Ethics Committee Composition
- Protection of subject rights, safety, and wellbeing
- Administrative support
- Review Process
- Decision making and post meeting activities
- 10) Record keeping and archival
NABH will appoint an assessment team. The assessment team will check whether the Ethics Committee complies to NABH standards by visiting the EC at location, by inspection, by review of document and records, and interview of staff and subjects. After the assessment, the report is provided to EC. The EC must submit the corrections within 3 months. Accreditation to an ethics committee shall be valid for a period of 3 years.
- Competing application form.
- Signed copy of ‘Terms and Conditions for Maintaining NABH Accreditation
- Self-assessment toolkit (conducted at least 3 months before application) submitted.
- Applicable documents (Manuals, SOPs, Protocol) of the ethics committee.
- Assessment Guidelines and Forms
What actions are required to be done by the site staff and the monitor if the signed informed consent was lost?
Dr Yash Merchant
All efforts should be made to recover lost documentation. These attempts should be documented in writing with a detailed “note to file”. The subject should be re-consented
Does US FDA allow use of MS-Excel for data management?
The US FDA regulations do not prohibit the use of MS Excel to collect data, provided the audit trials are robust that can’t be turned off and the authentication restricted e.g. use of unique IDs and protected passwords.
We wish to give a vitamin supplement purchased from market to our test subjects. Do we need any special labelling if we transfer the vitamins to a generic bottle?
The standard labelling for such a prescription bottle would include:
- Product and batch no
- Directions for use
- Date of filling the bottle
- Date of expiry
- The prescriber’s information
- Information/instruction for patient.