The Participant - as Patient or as Subject
Trimanos can also provide an invaluable source of information and reference for patients and for their representatives in making properly informed decisions about participation.
Trimanos is deeply committed to the safety and welfare of the patent, but equally to encouraging broad based participation in clinical research as one of the best ways to maintain the right balance between the interest of science, society and the commercial parties involved in drug or device development.
Perhaps the most critical success factor of all in trial management is good communications with the subject/patient, or with families or their representatives. Good communications is of the essence in the informed consent process; but informed consent has now to be seen not just as a moment when a patient commits to a trial. The whole trial, from design to evaluation has to be conducted within the context of maintaining active consent from all stakeholders; and this consent has to be earned, not taken for granted.
Maintaining a spirit of active consent has as much to do with the tone of communications and the ethical framework as any particular content. You can use Trimanos to maintain active consent. The patient module can answer the following key questions:
- What is a Clinical Trial?
- Why is a Trial Conducted?
- Why should I consider taking part?
- If I do, what is done to protect my health and safety, during and after the trial?
- What is the informed consent process?
- What if I change my mind?
- What is done with the results that have come from my taking part in the trial?
- What are my legal rights?
Trimanos can be used for building and maintaining communities of participants in trials. It readily lends itself to distributing periodic newsletters to subjects or publication of results which may in due course emerge and which subjects will have an interest in reading, even a frequently answered questions section can help service the needs of participants possibly even all over the world, in a very cost effective way.