Clinical Research Data Management 101

Clinical Research Data Management 101

  15.8.17

Over the past decades, scientists have written influentially and continuously of the need for large, controlled trials. These trials are considered the apex level of proof for directing clinical practice. Moreover, these commentaries do not contain any mention on managing these trials. Clinical trials sometimes fail to deliver as they lack structure, business-like approach, and practical application. A randomized trial involves a huge amount of investment with respect to time, money and humans; and hence it should be managed from its inception to its conclusion like any other business. Trial management is necessary among the key skills required to deliver high-quality results. A well-designed trial is the basis for resolving clinical questions and science alone cannot make it a successful one. Clinical trials require a coordinated process, irrespective of their size, cost, scope or duration.

 

What makes a successful trial?

Farrell and Kenyon suggested that actively managing all aspect of a trial makes it successful. The participants involved should be made comfortable with the trial and should be trained for the process. There are various methods of training including one-to-one training, distance learning methods, etc. Every project consists of a sequence, a set of actions to bring about results. The five stages that reflect the life cycle of a trial are:

  1. Initiating

  2. Planning

  3. Executing

  4. Monitoring and controlling

  5. Analysis and reporting

Therefore, development of a management plan is an essential factor for effective trial management. The steering committee should decide how the day to day activities of the trial will be planned and managed.

 

Trial manager

All research projects should appoint a trial manager. The trial manager should be involved in the project early in the trial design phase. This would save a lot of resources in terms of money and human labor.  The primary responsibilities and attributes of a trial manager are:

  • Taking a lead role in planning, coordinating and completing a project

  • Excellent communication and presentation skills

  • The ability to motivate others

  • Ability to manage the trial budget(s) and maintain accounts

Project planning

Planning the trial is one of the trial manager’s main responsibilities, but the whole team should be involved in the process for the plan to be successful. This involves:

  • Setting a clear objective

  • Deploying appropriate manpower

  • Putting time constraints

  • Tasks which need to be completed (to a pre-specified standard)

Communication

Without clear communication between team members, many problems may arise. For example, if a researcher doesn’t communicate to the other team members that a certain trail phase has finished, or a patient has left the trial, time consuming and costly mistakes can be made. Furthermore, investigators need to feel valued and should be made a part of the team answering clinical questions. This gives the team a sense of motivation and keeps them informed about the trial.

 

Efficient recruitment of trial participants

The success of a trial depends on the factor that it manages to recruit the specified participants to reliably answer questions.

 

Efficient systems

In this day and age, every trial needs robust computerized systems and processes that monitor the daily activities of the trial. There has to be a logical structure, precise documentation, and accountability of the processes involved in the trial for the data produced to be valid.

Data+ provides you with highly intuitive, user-friendly and reliable solutions to assist all your research processes. The systems are designed to collaborate data in order to produce reliable, accurate and fast results.