Clinical Trial Study Documents

Structured planning and preparation of study documents to prevent data loss and delays

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Study documents have a special status in clinical trials. Many study documents are necessary to ensure the data integrity of clinical trials such as the Clinical Investigator Plan (CIP), Case Report Forms (CRF or eCRF), Investigator`s Brochure (IB), risk management reports, consent forms or the Clinical Trial Monitoring Board Decision form.

In addition to professional and technical information, the documents for the clinical evaluation of medical devices include information about the organization and timelines of the clinical trial. These processes describe a study´s main and secondary objectives, collecting method and boundary conditions (e.g. inclusion / exclusion criteria). They provide insight into a study´s scientific background and set the personal responsibilities within a clinical trial (e.g. who is responsible for conducting the study?). They further predefine the ways how data within the study will be collected, processed, and statistically analyzed.

In conjunction with the documentation of the legal requirements (e.g. technical safety inspection reports), the study documents also form the basis of evaluation for authorities, ethics commissions, ethic boards or study register reviewers. In addition to the characteristics described above, well-planned study documents help to significantly increase the quality of a study. Predefined Standard Operating Procedures (SOPs), study rules implemented in the electronical case report forms (eCRF) as well as appropriate data management minimize the risk of errors (e.g. missing or incorrect entries during the study period) and data loss. In conclusion, stringently planned study documents (i.e. by implementing the CONSORT requirements in the study protocol) can also significantly reduce the effort for future international publications.

Since well-planned study documents also save time and money, CCMD would like to guide and support you in the preparation of all necessary study documents. Due to the long-term expertise of the CCMD members in the field of study documents, we can help you to ensure complete documentation and traceability of all data within your clinical trial. Through the legally compliant development and maintenance of all study documents, we would like to offer you the opportunity to handle submission processes at national authorities or ethical institutions efficiently and promptly.

In the field of study documents we offer the following services: