Reporting Requirements

For conducting clinical trials or clinical performance assessment examinations, it is essential to comply with the statutory reporting requirements. Beside the initial notification of local ethics committees, European (e.g. “Federal Office for Safety in Health Care” BASG – Austria, “Federal Institute for Drugs and Medical Devices” BfArM – Germany) or non-European authorities (“Food and Drug Administration” FDA – USA), periodic requests for extension of ethical votes are also part of these mandatory requirements.

In addition to obvious study documents such as the study protocol, a variety of different documents must be submitted to the authorities to ensure patient safety (e.g. reports on technical safety, case report forms or their electronic equivalent (eCRFs), risk assessments, declarations of conformity, operation manuals, informed consent, representations of the current state of the art in science or existing opinions of ethics committees). Moreover, also substantial changes to the examination documents or the occurrence of adverse events in the course of a clinical trial are subject to the statutory reporting obligations.

Generally, regulatory reporting requirements serve as an important measure to protect study participants and to assess the safety of the medical device. However, although reporting to authorities and institutions is reasonable and important, the associated processes – especially the initial filing – can cause unexpected delays. Particularly in case of non-compliance with essential deadlines (e.g. submission deadline to ethics commission), minor deviations can lead to substantial delays and thus negative financial consequences.

To prevent these potential delays, CCMD would like to assist with your reporting requirements. Whether in the case of an initial filing with ethics committees or periodic reports with authorities, we are happy to take charge of the communication with the required parties. CCMD possesses profound experience in developing and submitting clinical trials and their sub-parts (e.g. development of study documents; biometrical analysis; tailor-made, customized and validated case report form (eCRF)). We will help you to deal with reporting deadlines and responsibilities related to adverse events.