For this discussion respond to ONE of the following prompts by Wednesday.
What are the main data management tasks that are performed by your department? For what processes are you responsible? How is the case report developed – by a cross-functional study team? By a central case report form team? How is the process documented? Are there procedure documents (such as SOPs) that control the process of CRF development? Are you using paper, EDC or a combination? What is working well with your current process? What improvements do you think might be helpful to your organizations?
Does your organization currently use "nag" or "prompt" questions on your CRFs (e.g., "Were there any AE's", "Were there any conmeds", "Was there any Medical History")? Why or why not? Discuss a situation when having a "nag" question on a CRF may have either caused or prevented a problem.
Between Wednesday and Saturday respond to at least two other participants, including at least one person who responded to the discussion prompt that you did not select.
Best regards,SCDM Learning team------------------------------Annemarie WeiseEDUCATIONAL PROJECTS MANAGERSociety for Clinical Data Management Inc.B-1160 Brussels32-23202529------------------------------
Hi Emma, It's so great you have a team working together, it can be such a pain with teammates who do not communicate well. Does the process help with the SOP in place or would you think it more hinders the process? Thank you,
I'll be responding to the first question for this discussion as well. What are the main data management tasks that are performed by your department? For iiiI'what processes are you responsible? My department, Analytical Research and Development, is responsible for data integrity and data quality. The scientists in my department use our immunoassay analyzers and fulfill the role of a testing site for our Clinical department's validation studies. Document management and technical writing falls under my department as well which includes writing protocols and performing quality authentication on our study documentation. Currently I am responsible for assisting with database development and writing CRFs, as well as authoring our DMPs, data management guidelines and CRF completion guidelines.
How is the case report developed – by a cross functional study team? By a central case report form team? How is the process documented? As most of our studies are validation studies for blood tests they only consist of one or two pages. Those CRFs are generally handled by our lead CDM and reviewed by the CRAs and Clinical management until approved. Currently the process of CRF creation is captured in the DMP.
Are there procedure documents (such as SOPs) that control the process of CRF development? Are you using paper, EDC, or a combination? We maintain an SOP that describes the basic process for designing, creating, and distributing CRFs. Right now, we are only using paper CRFs. I have been experimenting with building eCRFs in Adobe Acrobat, we may implement this with our next study. It could depend on how soon we can get our EDC system implemented and even still when we conduct prospective collections we may use paper CRFs for specific sites based on their ability to use an EDC or not.
What is working well with your current process? We have very agile departments in that our Analytical, Clinical, and Regulatory departments are small enough that I think it helps us to make changes quickly when needed. There isn't as much red tape or hurdles to jump over to get something done or approved.What improvements do you think might be helpful to your organization? Being on the small side though everyone is so busy all the time and several our SOPs and the "Clinical Handbook" we use are outdated and do not reflect our current processes or were written to be very vague in the first place. I would, if I had the time, draft new versions of the SOPs and sections of the Handbook to cover more of the "process" that an SOP is supposed to describe. I've seen a lot of cases where members of the Clinical department don't fully understand each other's roles. I think it would be very important for people to know how their job affects someone further down the process stream and vice versa. As someone new to the group that has been a goal of mine, to understand how our clinical studies are conducted and help improve communication among the members of the different departments.
Hi James,With paper CRFs in the reading there was an exceptional amount of effort that goes into having a paper casebook. Do you have a standard paper that is used? Is it carbonless paper? Are the CRFs loose in like a 3-ring binder or is it bound? In the readings I was really interested in how pages could be added to a case book if it was bound. In your experience if you are wanting a short answer on the CRF do you "box" where the letters go? In the readings it was discussed that boxing or putting the comb format could reduce the ability for someone to accurately put the expected answer. I am curious what your and your department's experience has been or if this is something that has been discussed?Thank you,