How and when do we implement CDISC standards?

While each sponsor is keen on implementing CDISC standards, there are always questions as to how to implement them. One of the questions is, "At what point in the course of the trial right from its inception should the standards be implemented?"

The question is simple and the most logical answer would be "Right from the beginning".

While most sponsors look pay special attention to the correct and timely implementation of the SDTM and ADaM standards, regarding these as absolutely crucial from a submission perspective, the sponsors however are slow on implementation of standards such as PRM (Protocol Representation Model), CDASH (Clinical Data Acquisition Standards Harmonization).

All CDISC standards are designed to be 'in-sync' with each other (how 'synced' they actually are, is a point for another discussion) and it is important that all standards are looked at as a synchronized bunch first and individually later.

In an ideal world, the sponsors would start off implementing the CDISC standards right from the protocol development stage with the PRM, then move onto CDASH (correctly implementing them with the Controlled Terminology, Therapeutic Area User Guides etc) when its time to design the data capture systems. Implementing CDASH is crucial as SDTM and CDASH go hand-in-hand.

The time for commencing SDTM implementation is again a different question as ideally it should begin as soon as the data starts coming in (Some sponsors take this a step further and actually start off the SDTM implementation with dummy data while the data capture systems are being designed or undergoing user acceptance tests), however most sponsors will start off the SDTM implementation when they have 40-50% data in the system (some even do it later than that). ADaM implementation is again based on SDTM so, logically the earlier you start off with the SDTM implementation the better.

Most factors are not related to the expertise, skills, training, familiarity with the CDISC standards etc, the major roadblock is always the history and work culture of the organisation. For example, a sponsor who is late to join the party for CDISC implementation, will most definitely have poorly defined work processes or SOP's, they will almost always have people in key decision making positions who are used to working as per previous systems, processes etc, so will demand even more explanations, logic and time before making a decision.

As a result, even with the most sincerely good intentions at heart, things will move slowly in developing the sponsors internal processes for implementation of the standards. It is difficult to let go off the work culture and processes easily in order for something new. Sometimes the process can be so slow moving, that by the time they make up their minds and develop processes, there would be new standards which could affect them. Culture of the teams who have to follow the given processes is also very important. They need to see the bigger picture and prioritize their workflows as they start implementing standards.

CDISC Implementation is not the 'big' challenge it is made out to be, there is plenty of guidance for it, what is needed most of the time is a team willing to focus, think long term and gain valuable time and experience for the successive implementations to be done 'on time' without hassles.