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I wonder what others think about the role of SOPs or study manuals, if you are a MOP rather than SOP researcher. I am also not really sure about what you are supposed to use for what and when. In our site we have very different experiences, and number of SOPs depending on who is sponsoring the study. I am confused and would be interested hearing other peoples views and experiences.
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achapal
21 Jul 2010
I work in India and some of our trials are managed by sponsors such as CRO or drug companies and we run some of our own studies. We have learnt from our sponsored studies as they have come with their files and systems and lots of paperwork for their trials. We find it harded to do the same for our own studies but also that we do not need as many SOPs as the sponsored ones. I think this is because those are normally multicentered trials. I would like some template SOPs and more information about when SOPs are needed and when they are not.
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Jenny Mueller
15 Jul 2010
Dear Moses and Trudie,
Yes I agree with Trudie's explanation. I want only to add that the flow charts for 'hanging at a wall' are often attachments to the SOPs in out Unit as the SOPs should show signatures etc which is not needed for the 'flow charts' (but version and date).
We do not use MOPs generally, only SOP, unless the Sponsor provides MOPs.
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Trudie Lang
15 Jul 2010
Standard operating procedures set out the detailed steps and processes to make a protocol work. They are the key for translating the protocol into an operational study that everyone understands so ensuring the protocol is being consistently adhered to. They should not be arduous and should be highly pragmatic. They should be short and written by those who will be conducting the task. In our group we find it works well to get everyone together with the final protocol and talk through every step of the study as a process. For example we run through when and where the bloods are being taken and then how they get back to the lab and who is receiving them. When you 'walk' through the whole study as it would run for each participant, then each step and difficult issues come to light and it becomes clear where SOPs are needed. They are needed for the steps that if performed in a different or wrong way could impact the safety of the participants, an endpoint of the study, the validity of data or ethical standards (such as requesting consent). They are very important in multi-centred studies where there needs to be consistency in the data, but each site is different. Not every step needs a SOP, keep checking back to whether variation in conduct matters to the safety, ethics and data. Typically studies have between 5 and 10 SOP’s....not 70!
My ideal SOP is a single page laminated and stuck on a clinic or laboratory wall. There are some examples in the articles on this site. A MOP can be very helpful and many researchers groups have a single 'MOP' for the whole study and then short SOP's extracted as reminders, often placed on walls as posters. Whether you use a series of Standard Operating Procedures or a single Manual of Operations for your study it is important to have a version date as they can (and should!) change through the study. However well planned a trial there are always things that have not been thought about, or could be improved – so it is a quite OK to amend your SOPs and not be trying to work to ones that are not quite right. Does that help? Thoughts, comments others please.....