Writing SOPs - Part 2

In our last session, we created the first part of the SOP, which was the header. (See Part 1 if you haven't done that part yet). Today we are going to start on the 2nd major section of the SOP. This section consists of the Purpose, Scope, Background, Defintions and Abbreviations, and applicable Attachments.

Under the heading "Purpose", describe what the SOP is going to do. Hopefully, it will tell the reader the reason they are performing a task and how to do it.

The next paragraph in this section will be the SOP's "Scope". The scope describes the guidelines, regulations, internal procedures or protocol the task must adhere to. These will be the same criterion used to audit the task for compliance.

The "Background" section is optional. I use the background section to explain basic information about a task - if it is needed. If you are working with novices, the background section comes in handy to help them understand why they are performing the task and why they are performing it a certain way. If your co-workers are experienced people, the background section might not be necessary.

Definitions and Abbreviations are important when you write your SOP with non-standards. For example, everybody in the industry should know what FDA stands for so it is not necessary to put that in the definitions and abbreviations section. However, not everybody knows what WQATS stands for, so it is important to define "WQATS" as "Wilson Quality Auditing & Training Services" in the procedure. Always define abbreviations and terms that are used mostly at your company but not in the industry.

Attachments will be templates or diagrams used to guide the the user in completing the task. Since processes tend to change in the clinical research industry, many companies make templates a "sample" instead of a "100% controlled document". When I say "100% controlled document, it means certain sections and the format remains the same but content can change to match the intended process.

That's it for this session. Complete this part of your SOP. If you have questions on this process and what we've covered thus far, hit me up in the comments section.

Until next time..................

Have a QUALITY Day!!

Sarah

QA Talk

As the unemployment rate in America continue to rise, professionals are exploring opportunities to gain an edge in the interview arena. I'm glad to see this because that means more professionals are realizing the importance of certifications, training and experience. These items are extremely important and the competition out there is fierce! There are a lot of jobs availble in the UK for CRAs. Do you know enough about clinical trials in the UK to work there?

We should always get ready by enhancing our knowledge of research in other countries. Most sponsors conduct multi-centered and multi-cultural clinical trials anyway. Think outside your box. If you spend most of your time working with drug clinical trials, learn something about drug manufacturing and the entire process. At a minimum, you should have a snapshot view of that drug from "development to market". Diversify your knowledge. If you are a CRA, learn what a CRC does. You are probably not there only client so build a relationship with them and learn what a typical CRC day look like. CRC and the PI should take time to learn about the sponsor side of the clinical trial. Find out what happens to all of that data you collected. Diversification is more important than ever, now. I remember when I would go to a training session, the minute the time came to discuss device or tissue practices; I would leave. Not anymore. I want to know about it. I might find myself working in that field someday.

The more I learn now, the better for me later.

What about you? Are you diversifying your experience, your training, your knowledge? I would love to hear about it! Hit comments below and let us know about it.

Until next time......

Have a Quality day!!!