5 Areas Where We Struggle with the Adoption of CDASH Standards
We perform case report form (CRF) designs for hundreds of studies each year and have seen many different CRF specifications. In the past year or two, we have had more customers want to standardize on CDASH standards. When educating our customers about CDASH, we have started to see several recommendations that have made a big impact on the study teams. Below are the top 5 changes that have made the biggest impact on the CDASH groups we have seen.
1. Removal of extraneous comment fields. Many data managers are thrilled to finally be able to point to a reason to get rid of comment fields. The rationale listed in CDASH v1.1 is simple:
‘The collection and processing of free text requires significant resources and is of limited use when analyzing and reporting clinical data,’
AND
‘Entering text from these fields into the database is time consuming for data entry and requires CDM resources to review the text for safety information and inconsistencies with other recorded data.’
2. Questions that lead to other questions. Quite often there are questions on the CRF that are fishing for other data. An example with results is below.
a. Normal
b. Abnormal, not significant*
c. Abnormal, significant**
*Provide comment on abnormal findings
**Complete adverse event form for abnormal findings
In the example above, the investigator has been trained to enter significant abnormal results on the adverse event page, but data managers and study monitors have seen enough ‘mistakes’ where the investigator or study personnel has forgotten to list important results. They feel they have to ‘remind’ the investigator to review each result. CDASH recommends a simpler approach with the following example:
Was the <test> clinically significant? With a Yes/No option. If the test is clinically significant, there is no need to enter an additional adverse event.
3. How to capture a lack of results. No data is data. Huh? It is important to note when there are no results so that queries are not added asking for results over and over. From CDASH v1.1 “The data collection instrument/CRF should contain an indication that an assessment was not performed.” There are several approaches to this. For each test, there can be indicators for: None, Not Done, Not Applicable. In our EDC software, BioClinica Express, we offer a way to mark a page as ‘Not Done’ right in the system. This complies with the CDASH recommendation and is easy for the site to do.
4. Prompts for study compliance that do not map to CDISC SDTM.
Examples:
1. Were there any adverse events?
2. Did the subject take the study drug?
3. Did the subject complete the final visit?
Several examples of these types of data cleaning fields are noted in the CDASH Standard with the explanation: ‘The intent/purpose of collecting this field is to help with data cleaning and monitoring. It provides verification that all other fields on the CRF were deliberately left blank.”
Therefore if the intent/purpose of collecting a field is to help with data cleaning and monitoring, go ahead and collect it. These fields do not need to map to SDTM! This is a new and liberating statement, giving data managers permission to not map everything to the submission datasets.
5. Clarifying the data to be collected (Yeah!)
We have seen many different types of wording around the collection of data. Since CDISC provides standard wording, it makes the data manager’s job of designing CRF’s easier, and helps the study coordinator since they won’t have to figure out what is required differently for each study or sponsor.
Look for the CDASH Standard v 1.1 and the CDASH User Guide to be released shortly. In the meantime, what struggles have you had when it comes to the adoption of CDASH standards? I invite you to share them with me.