Online Course - CRF Design

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Module 2 Discussion

  • 1.  Module 2 Discussion

    Posted 05-21-2019 09:15
    Edited by Estelle Denion 07-29-2019 11:50



    Dear participants,

    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?

    OR

    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 Weise
    EDUCATIONAL PROJECTS MANAGER
    Society for Clinical Data Management Inc.
    B-1160 Brussels
    32-23202529
    ------------------------------



  • 2.  RE: Module 2 Discussion

    Posted 07-31-2019 03:35
    Hi everyone,

    I am answering for the first question-
    What are the main data management tasks that are performed by your department? For what processes are you responsible? Currently in my department, i am the only person doing most of the data management work. I help to create CFRs and also Databases on the doctor's studies requirements. I help to maintain these databases and update them periodically based on the protocol. I also do data completion guidelines and also training to other members that requires to use the CRFs/Databases. I do help to check the data quality and make sure that there are no errors in the database. My data cleaning skills are still quite novice and i do help to improve on that. So right now we outsource our data cleaning to other department.
    How is the case report developed – by a cross-functional study team? By a central case report form team? Right now, i am the one developing the case report form.
    How is the process documented? We usually dont have a proper documentation channel. Most of the information is discuss via emails/excel files and also face to face meeting. The doctors usually gives me a draft excel file with the fields that they want to collect and i help to group them up into different CRFs. I do hope to learn how to have a good process for documentation so that the doctors will feel confidence in trusting me with the CRFs development.
    Are there procedure documents (such as SOPs) that control the process of CRF development? I usually work based on their study protocols, on their primary outcomes and secondary outcomes. What are some of their goals in the study and i will translate it into a data field.
    Are you using paper, EDC or a combination? Both! My department mainly use REDCAP database.
    What is working well with your current process? I am able to sit down with the doctors and develop with them a CRF that they are happy to use. 
    What improvements do you think might be helpful to your organizations? I do hope to engage discussions with biostat team to understand their requirements on their side so i can prepare a better CRFs, usually when i send out a CRF draft for vetting, most of them dont really reply, so i dont get to learn. Also a downside to using our e-databases, they are all hosted in Intranet servers. So doing multi-site hospital sites will have it challenges as i have to create multiple databases in each site. Porting back the data at the end of the study is a headache.

    Thanks!


    ------------------------------
    Jonathan Lim
    Singapore
    ------------------------------



  • 3.  RE: Module 2 Discussion

    Posted 08-07-2019 08:22
    Hi Jonathan, 

    Hopefully being the only person doing most of the data management activities is not too overwhelming. I can relate though as we are currently without our database admin in the IT department and our senior Clinical Data Specialist so I am shouldering most of the DM work. I would also like to improve the documentation process for some of our clinical activities like CRF design. Right now I am trying to help them standardize some of their frequently used documents to reduce study start up time. 

    Your challenges with multi-site hospitals and multiple databases sounds like another issue I am dealing with in which we have several databases for our sample inventory. My problem is the databases were designed slightly different from each other as a new one was created over the years and I am trying to help clean the data and establish better inventory management practices so that the data can finally be combined into one database.

    I agree with you about joining two different data sets can be a big headache. 

    -James

    ------------------------------
    James Koch
    Scientific Application Data Specialist
    Fujirebio Diagnostics, Inc.
    Malvern, PA
    ------------------------------



  • 4.  RE: Module 2 Discussion

    Posted 08-05-2019 18:40
    What are the main data management tasks that are performed by your department?
    The main data management tasks include checking for data discrepancies, raising queries with site staff and following up their responses.

    For what processes are you responsible?
    In our department data management is a different process from database development and I am not involved in data management.

    How is the case report developed – by a cross-functional study team? By a central case report form team?
    The eCRFs are developed by the database programmers using templates where possible. The forms are reviewed and tested by a cross-functional team.

    How is the process documented?
    There is a review log for each stage of testing and several controlled documents that need to be signed off by the relevant parties.

    Are there procedure documents (such as SOPs) that control the process of CRF development?
    Yes we have developed a number of SOPs based on GCDMP recommendations.

    Are you using paper, EDC or a combination?
    We only use eDC.

    What is working well with your current process?
    We have a good development timeline with set checkpoints and required documents at each milestone which greatly aids with project planning and implementation.

    What improvements do you think might be helpful to your organization?
    I think better understanding of the development process by other members of the organisation who must contribute at certain timepoints would help mitigate delays.


    ------------------------------
    Eveline Niedermayr
    Peter MacCallum Cancer Centre - Australia
    Melbourne, Australia
    ------------------------------



  • 5.  RE: Module 2 Discussion

    Posted 08-06-2019 02:48
    Hi Eveline,

    Thanks for sharing,

    Is there a reason why you are only using EDC? Is it because there are multiple sites involved? For performing of remote data monitoring?

    May i know what EDC are you using in your workplace?

    Thanks!

    ------------------------------
    Jonathan Lim
    Singapore
    ------------------------------



  • 6.  RE: Module 2 Discussion

    Posted 08-06-2019 19:02
    Hi Jonathan,

    We do not use paper CRFs for many reasons including improved data integrity (not copying from paper which reduces errors, ability to trigger data discrepancy warnings at the time of data entry) and of course time savings in not having to transcribe from paper. The data is entered in real time and we can easily check for data forms that have not been entered in a timely manner and pick up data discrepancies much faster than if everything had been transcribed from paper. There is more work up front in building and maintaining an EDC but I think the time savings once the study is running is significant and we also end up with much higher quality data.

    Eveline

    ------------------------------
    Eveline Niedermayr
    Peter MacCallum Cancer Centre - Australia
    Melbourbe
    ------------------------------



  • 7.  RE: Module 2 Discussion

    Posted 08-07-2019 08:42
    Hello Eveline,

    As Jonathan and I both mentioned about wanting to improve our documentation practices, I like your process of using a review log at each stage of testing. Would this review log capture things like comments, feedback, requests for changes, approved changes, reasons for refused changes? 

    And to your final point about a better understanding of the development process by other other members, I agree with you completely as I mention the same thing, albeit in a different way, in my own post. My group likes to hold (almost) monthly lunch-and-learn sessions where people prepare a presentation to explain a process or product that they are working on. After my course in Developing a DMP from SCDM I hosted one of these meetings to explain what I learned and how it applies or can apply to our current environment. I think these have been helpful but there is still room for growth amongst the different teams. 

    -James

    ------------------------------
    James Koch
    Scientific Application Data Specialist
    Fujirebio Diagnostics, Inc.
    Malvern, PA
    ------------------------------



  • 8.  RE: Module 2 Discussion

    Posted 08-05-2019 18:55
    What are the main data management tasks that are performed by your department? CRF/Database design and development, source data verification, central monitoring of data, adverse event coding etc

    For what processes are you responsible? CRF/Database design and development

    How is the case report developed – by a cross-functional study team? By a central case report form team? How is the process documented? Developed in collaboration with the clinical trial project team, based off existing CRF templates, CRF working group meetings held to discuss more involved CRFs or CRFs presenting with issues in current trials

    Are there procedure documents (such as SOPs) that control the process of CRF development? Yes

    Are you using paper, EDC or a combination? eDC

    What is working well with your current process? Teamwork - good communication between disciplines is critical

    What improvements do you think might be helpful to your organizations? This course - to help us solidify and expand our current CRF library  




    ------------------------------
    Dr Emma Callegari
    Lead Database Design and Development Manager, BaCT
    Peter MacCallum Cancer Centre - Australia
    ------------------------------



  • 9.  RE: Module 2 Discussion

    Posted 08-06-2019 02:54
    Hi Emma,

    When you start off creating a new CRF, i understand you can use existing CRFs like demographics again. But for new study specific items, do the team list it down on an Excel document, or just based on the study protocol?

    Do you create a CRF first before creating the EDC? Or start to create EDC directly.

    Thanks!

    ------------------------------
    Jonathan Lim
    Singapore
    ------------------------------



  • 10.  RE: Module 2 Discussion

    Posted 08-07-2019 02:20
    Hi Jonathan, 

    It depends on the CRF - most we try to use CDISC documentation as a guideline but if it is something we haven't seen/built before we will ask the investigator what kind of data is required for the CRF and even if they have example CRFs they have used previously for other trials so we aren't reinventing the wheel. 

    The CRFs are created within the eDC system, we would focus on CRF design first before focusing on data checks, visit flow etc. 

    Kind regards, 
    Emma Callegari

    ------------------------------
    Dr Emma Callegari
    Lead Database Design and Development Manager, BaCT
    Peter MacCallum Cancer Centre - Australia
    ------------------------------



  • 11.  RE: Module 2 Discussion

    Posted 08-13-2019 21:25
    Hi Jonathan, 

    We usually use CDASH/SDTM and the protocol specifications as a guide and create a new draft CRF for discussion at regular team meetings. 

    Sometimes if it is not a CRF we are familiar with or a new tumour stream etc we will ask for example CRFs previously used or their field wish list before creating a draft CRF for the investigator/team to review. 

    Hope that helps!

    ------------------------------
    Dr Emma Callegari
    Lead Database Design and Development Manager, BaCT
    Peter MacCallum Cancer Centre - Australia
    ------------------------------



  • 12.  RE: Module 2 Discussion

    Posted 08-08-2019 18:04

    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,

    Sam 



    ------------------------------
    Samantha Carrington
    Loxo Oncology Inc.
    So. San Francisco CA
    (310) 995-0123
    ------------------------------



  • 13.  RE: Module 2 Discussion

    Posted 08-06-2019 12:34

    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.



    ------------------------------
    James Koch
    Scientific Application Data Specialist
    Fujirebio Diagnostics, Inc.
    Malvern, PA
    ------------------------------



  • 14.  RE: Module 2 Discussion

    Posted 08-10-2019 15:03

    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,

    Sam



    ------------------------------
    Samantha Carrington
    Loxo Oncology Inc.
    So. San Francisco CA
    (310) 995-0123
    ------------------------------



  • 15.  RE: Module 2 Discussion

    Posted 08-08-2019 17:59
    Hello!

    Currently we do use the prompt questions. For us it saves time for a site to answer the prompt question with a yes or no because it allows us to set expectations. For example if a site says the patient did not have an Adverse event there should not be AE forms completed. Having the prompt questions can also streamline what a site sees by only having a "yes" answer generating dynamic forms when expected. If a patient states that there have been no AEs, then no AE form will pop up for a site to be able to fill out. Sometimes having less forms available will reduce potential erroneous data entry. On the contrary if the form is not dynamic and the site incorrectly enters the prompt form and then fills out forms, data cleaning can sometimes be difficult. 

    Thank you

    ------------------------------
    Samantha Carrington
    Loxo Oncology Inc.
    So. San Francisco CA
    (310) 995-0123
    ------------------------------



  • 16.  RE: Module 2 Discussion

    Posted 08-13-2019 14:53
    Hi everyone,

    Please find my response for the first question:
     
    What are the main data management tasks that are performed by your department? For what processes are you responsible?
    In previous role, I supported Protocol review, CRF review,  was responsible for Edit check creation and Visualization tool development. I was also responsible for reviewing eCRF completion guidelines created by LDM. Along with these works, I was involved in Medical data review and query managment. I was also responsible for metrics of my studies and tracking the overall health of the ongoing study.
    How is the case report developed – by a cross-functional study team? By a central case report form team? There was library of CRFs. However, cross functional team used to look into study requirement and provide their inputs on the CRFs.
    How is the process documented? The entire process was documented in the project plan.
    Are there procedure documents (such as SOPs) that control the process of CRF development? There were client provided SOPs that one needs to follow.
    Are you using paper, EDC or a combination? I have worked on EDC platform.
    What is working well with your current process? I feel EDC is a very good platform and that data can be reviewed in real time.
    What improvements do you think might be helpful to your organizations? It will be better if we start considering lessons learnt from previous studies while developing CRFs. This will help in avoiding taking up major change request in the conduct phase of studies.

    Thanks and regards,
    Ujala Bhardwaj



    ------------------------------
    Ujala Bhardwaj
    Stockholm
    (072) 220-0386
    ------------------------------



  • 17.  RE: Module 2 Discussion

    Posted 08-13-2019 21:26
    Hi Ujala, 

    In regards to considering lessons learnt from previous studies do you implement these changes in a CRF library? Or how is this process handled?

    All the best,

    ------------------------------
    Dr Emma Callegari
    Lead Database Design and Development Manager, BaCT
    Peter MacCallum Cancer Centre - Australia
    ------------------------------