Atlas University Clinical Research Ethics Committee – Application

With the letter dated 02.03.2014 and numbered 56034207-514-10 of the Turkish Medicines and Medical Devices Agency of the Ministry of Health of the Republic of Turkey, the work of the Atlas University Clinical Research Ethics Committee established within the body of Istanbul Atlas University was allowed.

Applications to be made must be prepared in accordance with the provisions specified in the Guide on Research Applications prepared by the Turkish Ministry of Health, Medicines and Medical Devices Agency.

Legislation on the application process and drug research regulations .

Matters to be considered during the application;

¬ It is obligatory to submit the application form and all documents and forms related to your application file. All the documents and forms that you need to prepare regarding your application are reported in the guides where the files to be sent to the Ministry of Health for researches with drugs and biological products will be prepared. Please make sure to use the guides on the page that you can access from the legislation link in your file preparation .

¬ Archiving of all applications is mandatory. For this reason, the digital version of all documents and forms you have prepared with your application file should be submitted in 1 (one) CD.

¬ Pursuant to the article added to the Basic Health Law in 2011, “permission from the Ministry of Health is required in order for any treatment method or tool, or even if a license or permit has been obtained, to use drugs and compounds, traditional herbal medicinal products and medical devices on humans for scientific research purposes”. Note that your research project will be evaluated against these conditions.

The application must be made by preparing an “initial eligibility application file”. The first eligibility application file consists of Cover Letter , Application Form and related documents . Document Checklist It should be used for checking in order not to apply with missing documents during the application . Click here to download the Document Checklist.

FIRST APPLICATION

Cover letter:

It is signed by the applicant or the authorized person(s) on behalf of the applicant and added to the application file.

For download  the cover letter sample Click here.

Application form:

There are two forms for the first research applications, and the application form is filled according to the type of application and signed by the authorized person(s) and added to the application file.

Click here  for download  the Clinical Trial Application Form.

Observational Studies Application Form  for download  Click here.

Required documents specified in the Application Checklist and Application Forms are added to the application file, respectively. Below are the draft/support documents specified in the Application Checklist.

Click here to download the minimum information  document  that should be included in the informed consent form.

Click here  for download  the research budget form.

Click here to  download  the resume form.

Click here to download the Research Team List  document .

Biological Material Transfer Form  for download  Click here.

NOTICES:

Annual Notice

The progress of the researches is followed up with annual notifications. Annual notifications made in researches are reported until 31 January of the following year, based on the calendar year. (For example, the annual notification covering the date range 01.01.2022 – 31.12.2022 should be made until 31 January 2023.)  The institution and/or the ethics committee may request an annual notification at shorter intervals depending on the nature of the research. Annual notifications should be made from the time the trial is authorized until the end of the trial.

For download  the cover letter sample Click here.

Click here for download  the Annual Notification Form .

Outcome Statement

It notifies the Institution and the ethics committee of the end of the research within ninety days from the completion/end of the research.

For download  the cover letter sample Click here.

Click here to download  the Outcome Notification Form.

For download  BY/BE Summary Report document  Click here.

Security Notices

The sponsor should submit all safety statements to the Ethics Committee/Institution in accordance with the relevant legislation.

Flow chart for safety notices  for download  Click here.

(This flowchart contains an overview of safety reporting, and current legislation on clinical trials is essential in all cases .)

Safety statements are presented with the cover letter sample and the relevant documents specified in the cover letter examples.

CAO – SUSAR Statement Cover Letter Example  for download  Click here.

6 Months SUSAR Ordered List Statement Cover Letter Example  for download  Click here.

DSUR – ASR Statement Cover Letter Example  for download  Click here.

Click here to download the CAO Notices PivotTable  document.

Personnel Assignment Notifications

Among the research-related assignments, those that are notification nature and those that require decision and permission are determined by the Good Clinical Practices Guide. In assignments with a notification nature, the person concerned may be assigned to the research, provided that the Institution and the ethics committee are informed. However, the Institution or the ethics committee may cancel these assignments together with the justification if necessary.

Notification is made to the Information and Coordination Unit for the personnel assignments listed below.

– Associate researcher (assistant physician for observational studies)

– Research pharmacist

– Research nurse

– Viewer (Monitor)

– Field officer

– Data entry support staff

– For observational studies; Participating physician

– Other (qualified person to be assigned to assist in the conduct of the trial)

For download  the cover letter sample Click here.

Download the Application Form for  Personnel Assignment in Research Studies  Click here.

Click here to  download  the resume form .