let us know here....
Hello. We are not a big site and we only have a small number of research studies but we are planning more. We want to make a better job of discussing research with our communities. We are aware that others use community advisory bodies but we don't know where to start or how to approach this. Can anyone share their experiences and help us get started?
Please see the article on this and also the comment by Dorcas. You might wish to connect with her as she is an expert in this field
Good Day. We are setting up a new paediatric trial in India, looking at an in-patient intervention in malnutrition. We need to set up a data safety and monitoring board and we have not done this before. We would value any advice and any documents or instructions that could help. With thanks.
The UK MRC GCP guidelines http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002416 give some general guidance about the structure and terms of reference for an IDMC (or DSMB/C).
Also WHO guidance at http://www.sidcer.org/new_web/pdf/2006/operat_guidelines.pdf EMEA guidance at http://www.emea.europa.eu/pdfs/human/ewp/587203en.pdf and FDA guidance at http://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
Do make sure you get their Terms of Reference clear before they see any data, so hat everyone is clear what they are looking for and what actions they can or should take. The best advice is to try to get someone with DMC experience to Chair the group.
Thanks for the links above highly informative. We need to put some QC steps in place in our lab. Any ideas?
I am setting up a trial and need to have some guidance on writing SOPs. Also please what is the difference between standard operating procedures and a manual of operations. thanks to all
Hi Diaz and all.
My contribution is that the terms are used interchangeably as both gives guidelines to provide a standardization of a procedure.
SOP provides general information to be utilized throughout any research study (can cut across studies).
MOP is written for a specific study and will include SOP elements. The MOP should be very detailed. Usually, one starts with the SOP, and once general procedures have been written, the MOP will be easier.
Documents need to submit to DCGI for generic drug approval in India.
There is no definition for GENERIC DRUG in The Drugs and Cosmetics Act. Approvals are granted for NEW DRUGS.
122E. Definition of new drug.- For the purpose of this Part, new drug shall mean and
include- 2[(a) A drug, as defined in the Act including bulk drug substance which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims: Provided that the limited use, if any, has been with the permission of the licensing authority.]
(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for
certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved earlier for
certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of 3[Appendix VI] to Schedule Y.)
I am setting up a community based RCT where intervention is improved housing models for a specific disease prevention; outcome is measured by assessing and comparing the sp. disease burden among participants in the 2 groups.
I need help with sample size calculation, to get no. of houses to intervene. Thank you for answer or link related to this.
Hello Sumi. I would like to help, but my stats skills are not good enough. However try these links (I found them on this website)
1. The Trial Protocol Tool has a very useful sections on population, sample size, analysis strategies and statistical considerations: http://www.globalhealthtrials.org/articles/trial-protocol-tool/
Articles on study design and statistics for beginners:
I hope someone can give you specific help too - they might need some more information to work with.
A paper dealing with how to get the number of clusters for a cluster randomised trail is available via http://ije.oxfordjournals.org/content/28/2/319.full.pdf+html
Also the book Cluster Randomised Trials by Richard Hayes and Larry Moulton has a good chapter on sample size calculations. I have a spreadsheet which applies the formula from the book. It may be useful.