Thanks for your comments
Cody here, Project Coordinator for the GHT South African Faculty, my email address is firstname.lastname@example.org. Please feel free to email me with more information regarding your request for input from faculty members.
Great! Happy to hear the resources were useful! Thank you for promoting the site and let us know how you get on with your study's protocol and SOPs.
Thank you very much. I want through and I am refining the SOP.
I also register some Zambia researchers in the website. They are very happy.
Thank you for your message. It is really nice to hear from you and to hear about your trial.
Standard Operating Procedures (SOPs) are documents which clearly explain how to do a step or task, and who is responsible for all the steps within a given task, so that everyone in a team knows how to do this task and can perform it in the same way. So, for example, within data management you would have several different SOPs - one for how to enter data, one for how to deal with queries, one for how to lock the database, and so on.
SOPs can be updated as necessary, but because they form the 'how to' for each step of the trial process, it's important to keep track of which version is which (usually dating the footer is a good idea and keeping a log of all your SOPs and which one is the latest of each version).
The team working on your trial should read the relevant SOPs (whichever ones are relevant to thier work) and sign to say that they have read them. Through doing this, you can for example make sure that all your research nurses take consent in the same way - thereby standardising your methods.
I am sure that many of our members would also be happy to help, but there are some resources on the Network that might be helpful:
- This is a guidance article about laboratory SOPs with some downloadable templates on the right hand side of the screen
- Here is an overall discusson about SOPs with lots of useful references: http://globalhealthtrials.tghn.org/community/groups/group/process_map/topics/40/
- There are some downloadable SOP templates on the right hand side of the screen here, including one for monitoring, one generic one, one for CRF development, and one for how to develop SOPs: http://globalhealthtrials.tghn.org/articles/downloadable-templates-and-tools-clinical-research/
- Here is a discussion about SOPs and their review:
Regarding the study/trial Protocol here are some discussions and articles within the Network that could provide some guidance:
- How to create a Trial Protocol: https://globalhealthtrials.tghn.org/community/groups/group/process_map/topics/59/
- How to develop a Protocol:
- The Trial Protocol Tool:
I hope this helps. I am sure other members will also provide their input and share their experiences, so don't hesitate to ask if you have any further questions.
I am an Associate Professor in Medicine /Dermatology and Venereology at Chreso University and honorary lecturer at the University of Zambia. I also head the Dermatology and National STI reference laboratory and HIV research intervention department at University Teaching Hospital in Zambia.
I am currently the PI of a study that aims to validate the treatment algorithms of Sexually Transmitted Infections in three provinces of Zambia. I have written a proposal and a SOPs manual and would be very grateful if someone could advice me regarding what are the different parts/requirements this sort of documents should meet. I would also be grateful if someone among the members of the Network with experience in study protocols and SOPs could have a look at my documents and provide some input.
Prof Yassa Pierre
Thank you very much in advance for your help.