Are your data submission-ready?

Avoid the pitfalls and achieve a swifter approval process

Submitting semi-compliant or non-compliant data is a red flag to the regulatory agencies. At best, it will significantly slow down your approval process – at worst, it can lead to your clinical trial not being approved.

Therefore, data handling is imperative to ensure a smooth progression of your trial.

The cornerstone of ensuring submission-ready data is mapping your data in accordance with the CDISC data standards. However, transforming your data into CDISC formatting does not automatically result in submission-ready data.

In this blog post, we will walk you through 5 considerations to bear in mind in order to bring clarity to your data and heighten your data-quality.

Keep CDISC standards in mind while setting up your eCRF

Even though not all clinical trials are required to adhere to the CDISC data standard, complying to the standards can be an efficient approach to speed up the approval process or attract funding for future projects. 

Afterall, professional data management is important to everyone involved with clinical trials, and the purpose of CDISC is to further transparent and simple data interchange. 

Here, it can be very beneficial to consider the CDISC SDTM and Controlled Terminology (CT) formats early in the process – preferably when you set up your eCRF.

Keeping the CDISC data standard in mind while setting up the eCRF can save you considerable time and resources later on in the clinical trial because converting your data to the SDTM format will be significantly easier.

CDISC stands for the Clinical Data Interchange Standards Consortium, a global initiative that establishes standards for data in the pharmaceutical industry. 

These standards facilitate the seamless exchange of clinical research data between research sponsors and regulatory bodies, enhancing transparency and efficiency.

Both SDTM and ADaM are CDISC standards.

If you are submitting your data to the FDA, for instance, you must adhere to SDTM and ADaM. SDTM is a framework defining how to organise the structure, content and attributes of the clinical data. ADaM, on the other hand, is designed to support efficient statistical analysis and to facilitate the regulatory review process. 

Adhering to these standards is a requirement for submitting data to certain regulatory agencies and can help you speed up the review process.

Provide the reviewer with the tools to easily decipher your data

Consistent data plays a pivotal part in propelling a clinical trial forward and lays the groundwork for a smooth review process. Considering the increasing complexity of clinical data, this is a very important step. 

Three of the most important documents to help others easily navigate through your data are the SDTM annotated CRF, define.xml and reviewers guide. 

The purpose of these documents is to help the relevant stakeholders or reviewers find all relevant data and navigate through the submitted data with ease. It is noteworthy to mention that these documents must follow specific guidelines regarding their formats. You can find the guidelines for the SDTM annotated CRF here and for the define.xml and reviewer guide here.

Do not wait to validate your data until the 11th hour

We have already mentioned the high complexity of clinical trial data, but it is also relevant to mention in regard to data validation as it is nearly impossible to track the submission readiness across such large data sets. 

For that reason, utilising a tool like Pinnacle 21 is key. The solution is widely recognised for the ability to validate clinical trial data against CDISC standards and notify potential discrepancies. 

Utilising Pinnacle 21 allows you to reprogram and fix potential issues in advance to speed up the review process and document the issues that can not be resolved in the reviewer guide section designated to Pinnacle 21 issues.

Be prepared to meet different requirements

There are multiple stakeholders and regulatory agencies involved throughout a clinical trial. 

That means that you may have to balance different preferences or requirements at different times. One example is conventional and SI units in lab measurements. Including both is one way to cater to the diverse preferences of reviewers and regulatory bodies worldwide while ensuring alignment with global standards.

Moreover, the lengthy nature of a clinical trial can make it challenging to foresee every request or requirement that may arise during a clinical trial.

So, taking certain precautions throughout the trial can be a good idea. 

Another example that can cause a serious headache is the accessibility of your raw data. While it might be natural to merely request your analysed data in the correct format, such as SDTM, it could also be a good safety measure to request the raw data.

There are examples of clinical trials halting due to the regulatory agencies’ requests for raw data – something that can be difficult to track down years after the data collection.

Keep an eye on future demands

The landscape of clinical trials is continually evolving, and this makes it crucial to stay informed.

In general, the industry is taking great strides in moving towards more versatile and accessible formats. For years the most used format has been SAS V5 transport files (.XPT), and they are still the required format by most regulatory requirements. 

However, this format poses certain limitations in regard to text and naming. Therefore, we see a notable interest in moving towards formats such as JSON in order to solve the challenges. 

It requires a meticulous approach to stay on top of the stringent guidelines and keep abreast of ever-evolving requirements. However, it is ultimately the fastest route to the speediest approval process.

BioStata is your professional clinical research organisation

At BioStata, we help sponsors keep their clinical trials on track with high-quality data. 

We offer complete CDISC services, and we are available to help with advice on how to data collect in the best possible way as well as prepare your clinical trial data for submission in accordance with the CDISC standards whether you wish to submit data from an older study, an ongoing study or you are in the process of setting up a new clinical trial. 

Are you looking for assistance with a clinical trial? 

We are happy to help you find a solution that suits your needs.

Let us discuss your data

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