Masterstudiengang "Drug Regulatory Affairs"


Subject information and informed consent for subjects participating in clinical trials: How good documents can look like ***

Heike Mehrer (Abschlußjahr: 2010)

Language: English

According to ICH-GCP it is required that potential study participants are informed about the aspects of the clinical trial they are asked to participate in. This is done through a discussion between the subject and the investigator. Additionally subjects receive a written information about the clinical trial and have to sign a consent form to document their decision.
When preparing a subject information sheet and informed consent form sponsors have to take into consideration the applicable regulations of the countries where they want to include subjects into their clinical trials. Additionally, they need to keep in mind the subjects´ need for documentation that is understandable and readable.
In several countries ethics committees and/or regulatory authorities have prepared templates for the subject information sheet and informed consent form with the aim to ensure that applicable local regulations and subjects´ needs are reflected and guidance to sponsor is provided.
A review of several templates shows that there are similarities and differences in understanding of how good documents can look like. Common to all templates is that they are based on the elements of ICH-GCP to various extends whereas differences can be seen in the layout of the documents or the size of the documents.
Based on the results of the evaluation of the local regulations and templates this thesis develops a model documentation intended for adult subjects that are able to consent. It reflects all elements of ICH-GCP and those additional requirements issued by ethics committees and/or regulatory authorities or stated in local regulations that are common to several templates. Any further guidance provided by ethics committees and/or regulatory authorities that improves the readability and understandability of the documentation for the subject has also been taken into account.
During the development of the model documentation it occured that it is not possible to implement all country or site specific eventualities in one model, otherwise the model would not be easy to handle for sponsors anymore. It is also required that the suggested templates need to undergo country or site specific adaptation before they can be submitted to the applicable ethics committees and/or regulatory authorities for approval and subsequently be used for the information of subjects. Reasons for the need for further modifications can be found in the differences in regulations, education and culture.

Pages: 59
Annexes: 20 (220 pages)