Clinical Trials Sponsored by the Industry
Initial Admission
Coordination of administrative, financial and legal issues of clinical trials carried out in our Faculty is provided by PROKOM.
All studies covered by the regulation on clinical researches; observational studies, medical device studies, drug studies under early access program, could only be started after the completion of approval process by PROKOM.
It will be beneficial for the sponsor to contact PROKOM a sufficient time before the application. Since the evaluation of clinical research contracts may take time, it is recommended that the contracts should be submitted to PROKOM at a considerable time before the planned patient recruitment date of the study.
Documents required during the application process
Sponsor can apply to PROKOM simultaneously with the Ethics Committee application. In studies that require the approval of the Ethics Committee and the Ministry of Health, while these stages are continuing, the process concerning Ege University is carried out by the PROKOM Commission that meets once a week. The Commission examines the documents submitted through an electronic system (KAYS), evaluates the study budget and institutional suitability of the study, and submits the study to the Dean's approval. It is aimed that the whole process will be completed until the approval of the Ministry of Health comes.
1- Approval process for the projects evaluated according to the R&D incentive law and receiving payment through the Revolving Fund Directorate of the Hospital
2- Ege Budget Form
3- Request forms for the trial-related procedures that will be performed in the Hospital of Ege University
4- Stamp (Including information about the trial i.e. trial code)
5- Receipt for PROKOM file evaluation fee
6- Ethics Committee application file
7- Ethics Committee approval
8- Approval of the Ministry of Health for studies deemed necessary by the legislation
9- Contract
Note: This process should also be followed in studies that is supported by governmental institutions such as TÜBİTAK, BAP or other associations.
Ongoing Studies
Budget and Contract Revisions
In cases when changes required in budgets and/or contracts of ongoing studies, an application should be made to PROKOM stating the brief justification for the change.
The document which is sent to the clinics to report the daily procedures of each patient participating in the study should be filled in accordance with the suggested format and it is mandatory to send the document to the mail adress masrafdokumu.prokom@gmail.com every day until 16:00.
Expense Documents
In order to compare and verify the expenses, the subject protocol numbers and visit/examination dates registered with the sponsor should also be submitted in the appendix of the petition.
The expense documents given by PROKOM includes only the list of the physical examinations and procedures performed in the Hospital of Ege University, the payments to investigators are not included in the expense document.
Closing The Trials
All trials that are completed or terminated for any reason (including the trials recruiting no patients) must be declared to PROKOM. A copy of all payments made to the Revolving Fund should be attached to the petition regarding the closing request. The registration code opened specifically for the study in the Hospital Information Management System is closed as of the date of petition, thus preventing the addition of new transactions to the trial.
It is the responsibility of the sponsor or his representative CRO to notify that the study is closed.
