• New Application
• Amendment
• PI Change
• New trial site
• End of study
• Revised Submissions

New Application

Documents to be submitted (each as a separate PDF):

• Cover letter, dated and signed
• Summary (ca. 1 page)
• Filled out Checklist for Other Studies (currently only in German) (please download the checklist to your PC to fill it out). Your application documents will be checked on the basis of this checklist. At the same time, the checklist serves as a self-check and helps you to avoid later requests for additional submissions on the part of the Ethics Committee. Before you upload the study protocol and the information sheet(s) and the informed consent document(s), please check the documents using this checklist. If all items applicable to the study have been considered, please confirm this by placing a check mark in the gray box. 
  Furthermore, we have prepared a Guideline for Other Studies (currently only in German) for you to help with the wording of the study documents, in which you will also find explanations for special cases and pre-worded text blocks.
• Form for initial application (PDF form) (currently only in German) (please download to your PC to fill it out). 
• Information sheet(s) indicating the version and the date in the header or footer of the document 
• Consent form(s) indicating the version and the date in the header or footer of the document
• Study protocol indicating the version and the date and signed
• If applicable, statements from other ethics committees 
• Current curriculum vitae of the principal investigator, dated and signed
• Cost absorption declaration (does not have to be submitted for an academic qualification project!) 
• If the application is for an academic qualification project: Confirmation by the supervisor of the thesis. (The confirmation must contain the title of the qualification project and the name of the person preparing the thesis!)
• Other attachments (e.g., questionnaires developed for the study or interview guidelines [each with the indication of the version and the date], power of attorney for correspondence, declarations of conformity and instructions for use for medical devices, insurance documents, etc.)

In the following table you will find an overview showing which documents require a signature, a version number, and a date in the document.
 

Amendment

An amendment is a change that is undertaken after the commencement of the study (i.e., after receipt of  the statement of the Ethics Committee). No distinction is made between substantial and non-substantial amendments for Other Studies. Therefore, formal amendments of the study documents should also be submitted to the Ethics Committee.

Amendments are to be distinguished from so-called content-related revised submissions or formal revised submissions (see below). 

The following applies to every amendment: the changes made must be marked with the aid of the automatic change tracker of the word processing program used (“track changes mode”) and the date and the version of the changed document must be updated.
It is inadequate to merely use a color to highlight passages that have been changed! 

You will find instructions for the common word processing programs on the Internet: 

• Microsoft Word
• Libre Office
• Open Office
• Pages

 

Documents to be submitted (each as a separate PDF):

• Amendment form (Word document), dated and signed by the principal investigator 
• Amended study documents with tracked changes using the “track changes mode”, with updated indications of the version and the date, and if necessary, signed (see table above)  
• For studies for which the HD Ethics Committee has adopted an existing vote of another ethics committee, the corresponding statement regarding the amendment of the same ethics committee must be attached. The same prerequisites apply as for an initial application  

Change in the principal investigator

Any change of the principal investigator must be submitted to the Ethics Committee as an amendment. The following documents are to be submitted for this purpose: 

• Amendment form (signed by the previous principal investigator)
• The most current version of the study protocol, signed by the new principal investigator 
• A current curriculum vitae of the new principal investigator (dated and signed)

Insofar as the study protocol has been formally adapted as part of the change in principal investigator, a tracked changes version using the “track changes mode” is to be attached.
 

Subsequent report of another trial site within the jurisdiction of the Heidelberg Ethics Committee

The participation of another trial site located within the jurisdiction of the HD Ethics Committee in the study must be reported to the Ethics Committee as an amendment. Please note that the correspondence on the study is directed at the current principal investigator of the initial trial site within the jurisdiction of the Ethics Commission. However, the votes apply to all physicians within our jurisdiction and thus also include the staff of the new trial site. The following documents are to be submitted to report an additional trial site:

• Amendment form (signed by the current principal investigator)
• The most current version of the study protocol, signed by the responsible physician at the new trial site 
• A current curriculum vitae of the responsible physician at the new trial site (dated and signed)

Insofar as the study protocol has been formally adjusted as part of subsequent reporting of another trial site , a tracked changes version using the “track changes mode” is to be attached. 

Reporting the end of a study

The end of a study is to be reported to the Ethics Committee. Moreover, a final report containing a summary of the results and the conclusions of the study should be submitted to the Ethics Committee within one year after the study ends. The final report should also be submitted if the study was prematurely terminated. As an aid, you will find a sample template for a final report below. The following documents must be submitted to report the termination of a study:  

• Informal letter stating that the whole study has been terminated or that the study has been terminated at the local trial site 
• Final report (submitted within one year after the termination of the study) 
   

Revised submissions

General information (formal/ content-related)

The Ethics Committee makes a distinction between formal revised submissions and content-related revised submissions.

All revised submissions required by the Ethics Committee prior to an assessment of the respective application (initial application or amendment) during a meeting, are formal revised submissions. They will be requested by office employees either via email or in a letter of receipt ("Eingangsbestätigung").  
Revised submissions in response to additional requests from the Ethics Committee after the assessment of your application during a meeting, are content-related revised submissions.  You will be notified of such requests in a letter entitled “Inhaltliche Nachforderung”. 
Independent of the nature of the revised submission, the following must be complied with: 

• The revised submission must be made via the Online Platform of the Ethics Committee (see above).
• Only those documents that have been requested should be submitted at this time. Please refrain from submitting additional documents “pro forma”. This increases the workload for the office and can therefore lead to delays in the processing of your application. 
   

Content-related revised submission

For content-related revised submissions the Ethics Committee requests that the following also be considered:

• Only those changes may be made to the documents which have been requested by the Ethics Committee in their letter (subsequent request for content-related revised documents ). All changes exceeding this may be submitted as a subsequent amendment (see above) after the conclusion of the assessment procedure (i.e., after receipt of the “vote”). 
• Changes in the documents must be tracked using the automatic track changes mode of a word processing program (see above). 
• For documents that must contain a version and/or a date (see list of documents to be submitted for an initial application), the version and/or the date must be updated. The designation of the version is left to the applicant (e.g., Version 1.0 → Version 1.1 or Version 1.0 → Version 2.0). 
• In addition to the version with the tracked changes, one version in which the changes have been adopted, should be submitted (clean version).
• If the study protocol is changed, the revised version must be signed by the principal investigator. 
   

Further templates

• Notes on Biometrics (German only)
• Template for an end of trial report according to the Declaration of Helsinki