Patients’ safety is paramount. Therefore, in some situations, (parts of) the study protocol (particularly safety information, permitted and prohibited medication, medication schedules etc.) must be directly available for employees with a treatment relationship with the patient. On the other hand, as a sponsor of a clinical trial you want to handle the disclosure of any sensitive information with care and in addition, in case of an external sponsor, confidentiality of trial information has been contractually agreed between the sponsor and Amsterdam UMC or the AMR BV.
This places legal restrictions on the public access of trial documentation where the contract stipulates that this documentation is only accessible to employees who are part of the study team (mentioned by name on the delegation log of the trial).
Therefore the use of a standard disclaimer is mandatory. Any employee who wants to post (parts of) confidential trial documentation in K2.Iprova (e.g. a study protocol, manuals, patient information and consent form which are all property of the sponsor or a ‘moederprotocol’) is obliged to make use of the standard disclaimer either as a cover page or paste it in its entirety in the trial document, so that every employee with access to K2.iProva makes a conscious decision as to whether he/she has a legitimate reason for access.