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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 Ramakrishnan
NABH 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:
  1. Authority for formation of Ethics Committee
  2. Standard Operating Procedures (SOPs)
  3. Ethics Committee Composition
  4. Protection of subject rights, safety, and wellbeing
  5. Administrative support
  6. Review Process
  7. Decision making and post meeting activities
  8. Monitoring
  9. Self-Assessment
  10. 10) Record keeping and archival
The Ethics Committee should make an application to NABH by sending
  • 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
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.

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?
Ishan Kulkarni

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?
Shankar Ganguly

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.


Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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Vishal Apr 23, 2017 1:31 AM
During ongoing clinical trial new central laboratory added then Investigator undertaking(IU) required to update? Addition of new central pathology required to notify DCGI?
Vishal Apr 23, 2017 1:30 AM
During ongoing clinical trial new central laboratory added then Investigator undertaking(IU) required to update? Addition of new central pathology required to notify DCGI?
Dhaval Gohel Apr 16, 2017 11:20 AM
If we use MS Excel for data management and any other purpose for clinical trial then it is necessary to validate that ms office software. Please provide your views regarding this area.
 
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