10. FAQs

Here you can find answers for freqently asked questions. Please use the search box below to pre-filter the list based on your search terms. If you have further questions, please contact the contact person of the respective DZHK establishment.



From where may I obtain the ethics documents for a study?

The “operative contact” of each main study centre holds the most recent ethics documents for the study. The enrolling centre or the main study centre will prepare a local ethics application in consultation and will attach to it the central ethics documents as well as the central positive ethics vote. The DZHK Ethics Project will support all parties involved with questions, uncertainties, or votes and further coordination tasks. An enrolling centre will inform the main study centre as soon as it receives its local positive vote and will provide the documents to it.

Answered by: Ethics Project

Which criteria are important for the TTP while verifying the ICs?

 

  • Presence of/completeness and at least partially readability on the informed consent of:

o   IC-Scan

o   Information about optional modules

o   Last name, first name, gender, date of birth, place of birth, pseudonym, date of the participant’s signature

o   Date of the signature of the enlightened doctor

  • Presence of:

o   Signature of the participant,  place (at the signature area of  the participant)

o   Last name, first name, signature, date of signature, place (in the signature area of the doctor)

  • The TTP matches the information on the IC with the information in the TTP database:

o   Last name, frist name, gender, date of birth, place of birth, pseudonym of participant

o   Optional modules of informed consent

o   Used version of IC scan

 

How do I correct an informed consent (IC)?

The information sheet: “Processing Notes on How to Resolve Quality Deficiencies” explains how the quality report on informed consent (IC) deficiencies must be read and what kind of action it incurs.

When using an upload ticket, you must remember that every IC of each study participant must be saved as a distinct (= separate) PDF file. ICs of several study participants or several ICs of an individual study participant must not be transferred using one single PDF file.

Information on the transfer of several files with one upload ticket is available in FAQ entry “May I transfer several PDF files using one single ticket?”.

Answered by: Independent Trusted Third Party (TTP)

Which browser am I using?

With the help of the descriptions and pitures mentioned below, you can check which browser you are using.

firefox A blue ball with a red fox = Mozilla Firefox.

ie A blue “e“ with a yellow line = Internet Explorer.

chrome A blue circle surrounded by another circle with red, green and yellow parts = Google Chrome.

How to check which browser version you are using please click here.

What is a signature?

A signature is a text section which is often located at the end of e-mails for example and which containes information about the sender.

Example of a signature of the Universitätsklinkum Schleswig-Holstein Campus Lübeck with contact data and image elements:

Answered by: Independent Trusted Third Party (TTP)

May I transfer several PDF files using one single ticket?

You may transfer several files to the Independent Trusted Third Party (TTP) using one single upload ticket. If so:

  • The individual files must be available at the time of ticket submission.
  • Files must not exceed a size of 2 MB.
  • Each IC scan of a participant must be a separate PDF file.

Answered by: Independent Trusted Third Party (TTP)

What information must be made indecipherable in case of revocation / study exclusion?

A revocation (R) or study exclusion (SE) requires that the pseudonyms are rendered indecipherable on all study documents of the study participant.

This does not apply to studies conducted in accordance with German Medicinal Products Act (AMG) and German Medical Devices Act (MPG)!!! This rule of exclusion currently includes the following studies: APPROACH-ACS-AF, SMART-MI, FAIR-HF2. (As of: 10/01/2017)

Answered by: Independent Trusted Third Party (TTP)

Which browser version am I using?

Mozilla Firefox:

  • Open the menu (click the three horizontal lines top right)
    aaaaa
  • Click the question mark on the bottom right (open menu "Help")
    aaaaa
  • Choose the point „about firefox“
    aaaaa
  • A new window opens, which shows you the latest version of your Firefox
    aaaaa

Internet Explorer:

  • Open the menu by clicking the gearwheel symbol top right
    aaaaa
  • Choose the point "About Internet Exporer"
    aaaaa
  • A new window opens, which shows you the latest version of your Internet Explorer
    aaaaa

Google Chrome:

  • Open the menu by clicking the three horizontal lines top right
  • Choose the point "help" and then "About Google Chrome"
  • A new window opens, which shows you the latest version of your Google Chrome browser

I do not have a static IP (Internet Protocol). May I still request a client certificate?

No. This scenario is not supported. If applicable, please contact us.

Answered by: Independent Trusted Third Party (TTP)

I have questions concerning the secuTrial access.

For any questions regarding the user account in secuTrial you can contact our data handling colleagues in Göttingen.

Datenhaltung des DZHK

Universitätsmedizin Göttingen

Institut für Medizinische Informatik

Robert-Koch-Straße 40

37099 Göttingen

Phone: 0551/39 13175

Fax: 0551/39 22493

Email: dzhk.support@med.uni-goettingen.de

Answered by: Independent Trusted Third Party (TTP)

How do I submit a revocation / study exclusion?

Please request an upload ticket for submitting a revocation / study exclusion as described in “DZHK-SOP-TTP-02-Record Revocation and study exclusion".

Answered by: Independent Trusted Third Party (TTP)

In which database will the informed consent scans (IC scans) be saved?

The IC scans will be saved in a database at the TTP. The TTP has been commissioned by the DZHK to centrally manage the informed consent forms of the study participants and to maintain the information for future Use and Access requests. 

For more detailed information please refer to the Process Description and Data Protection Concept (ZDM).

Answered by: Independent Trusted Third Party (TTP)

How will the IC test reports be sent?

  • The IC test reports are created per study and study site

o   Example: TORCH-Heidelberg, TORCH-Mannheim etc.

  • The IC test reports will directly be transmitted encrypted via email from the TTP to a specific study contact.

o   This contact has already been named by the study coordinators or transmitted on the form Notification for Activation of a Study Site.

o   If there should occur changes by staff turnover, please prompt inform us the new contact with all contact data of the respective site.

o   For the correction of anomalies the mentioned contact person is responsible to distribute the IC test report to the staff.

  • The password to open the file has been communicated to the contact person via email. The email will only be sent once. The password stays the same for each report.

What is TLS 1.2? Does it require any installations?

TLS 1.2 is a type of encryption your browser is using to communicate. For protecting the transfer of IDAT from the study centre to the Trusted Third Party uses encryption, similar to home banking. The TTP has been required by the State Data Protection Commissioners (of Mecklenburg-Western Pomerania and Lower Saxony) to stop supporting legacy encryptions such as SSL or TLS 1.0 / 1.1. We therefore only accept TLS 1.2. 

Using TLS 1.2 does not require any software installation. Your administrator may need to configure the browser accordingly. More detailed information on this topic is available in the Information Sheet for Client Certificate and secuTrial.

Answered by: Independent Trusted Third Party (TTP)

How do I know, if my browser supports TLS 1.2?

Open the following link in your browser: browser-test.med.uni-greifswald.de

  • If the following or a similar message is displayed with a red background, the browser does not support the necessary encoding. In this case, update your browser or use another one.
    aaaaaBrowser unterstützt TLS 1.2 nicht
  • If the following message is displayed on a green background, your browser does support TLS1.2.
    aaaaa

A study participant has already been enrolled into the study at another study centre. What procedure should be followed?

The following procedure has been agreed upon for such a case:

  • Compare the personally identifiable information (IDAT) with a Trusted Third Party employee:
  • IDAT match?:
    • Please ask the study participant whether she/he is already participating in the study at the first enrolling centre.
    • Person is already participating?:
      • Destroy any biological materials potentially available at your study centre.
      • Only the informed consent provided to the first enrolling study centre is valid, unless there are substantial changes to the documents that might affect the decision to participate.
      • Please send a short notification to the study participant that the biological materials have been destroyed and that:
        • a) the second informed consent is invalid, but that the original informed consent from the first study centre remains valid, or
        • b) that the informed consent form signed at your study centre is valid and that thus it will replace the original informed consent provided to the first study centre.
    • Person is not yet participating?:

Caution: If the person has moved, the originally signed informed consent form will remain valid, as long as the version number remains the same. Please contact the TTP if such occurs, so we can activate you for further editing of the study participant.

  • No IDAT match?:
    • Please review the collected data at your study centre.
    • Please review the data entered into secuTrial®.

Answered by: Independent Trusted Third Party (TTP), Ethics Project

A pseudonym is not recognised / found in secuTrial®.

If you cannot find a pseudonym in secuTrial®, the creation process of a study participant has probably been cancelled.

Please follow the steps described in entry “The creation process has been cancelled prior to informed consent (IC) upload. What now?”.

Answered by: Data Handling unit

The informed consent (IC) cannot / could not be uploaded. What may be the cause?

Please refer to the following FAQ entries:

“The creation process has been cancelled prior to informed consent (IC) upload. What now?”

“Uploaded PDFs (ICs) do not appear in the preview. What may be the cause?”

“The uploaded informed consent scan (IC scan) has not been sent to the Independent Trusted Third Party. What may be the cause?”

Answered by: Independent Trusted Third Party (TTP)

Which fields on the informed consent form (IC) may the study staff complete in advance?

The study staff may complete all fields except for

  • the optional modules (“I further agree that ... "),
  • the signatures of the participant,
  • and the date of study participant's signature of an IC.

However, the study participant should be asked to review the data.

Answered by: Independent Trusted Third Party (TTP)

Uploaded PDF’s (IC's) are not shown in the preview. What may be the cause?

  1. Please check if the the PDF Reader is installed and activated.
  2. Deactivate the popup blocker (please contact your local administrator if necesarry).

1. Check if a PDF reader is installed.

Mozilla Firefox:

  • Open "options" via the menu (three horizontal lines top right)
    aaaaa
  • A new tap opens, click "applications"
  • In the list "file type" you find „Portable Document Format“ (PDF), next to it the option "preview on Firefox" where you can open PDF documents directly in your browser
  • Close and reopen your browser

Internet Explorer:

  • Click the gearwheel symbol (menu top right)
  • Choose "manage add-on"
    aaaaa
  • Choose Adobe PDF in the window that opens and click "activate"!
  • Close and reopen your browser
    aaaaaClose

Google Chrome:

  • Enter „chrome://plugins“ in the address line to previwe all plug-ins
  • Choose the pdf viewer or an alternative program (Adobe Reader)
    aaaaa1
  • Click "activate"
  • Close and reopen your browser


2. Deactivation of pop-up blocker

Mozilla Firefox

  • Open the menu by clicking the three horizontal lines top right
    aaaaa
  • Choose the point "options". Afterwards, a new window opens.
    aaaaa
  • Click then Privacy & Security
    aaaaa
  • Scroll down to Permissions, there you can set your pop-up blocker
  • Close and reopen your browser

Internet Explorer

  • Click the gearwheel symbol (menu top right) and then click internet options

  • Choose the tab privacy
  • There you can set your pop-up blocker

Google Chrome

  • Click the menu top right
  • Click settings

         

  • Click show advanced settings
  • Click "privacy" and then content setting

        

  • At "pop-ups" choose the option allow all sites to show pop-ups
  • Close and reopen your browser

Answered by: Independent Trusted Third Party (TTP)

The uploaded informed consent scan (IC scan) has not been sent to the Independent Trusted Third Party. What may be the cause?

When using the browser’s “Back” button, correct functioning of the secuTrial®-embedded pages of the Trusted Third Party is not guaranteed. This may be why the scan has not been sent.

Answered by: Independent Trusted Third Party (TTP)

I forgot to print out the LIMS or pheno pseudonym or the master data sheet.

1. Has the master data sheet been printed out?

- on your master data sheet you find the LIMS and pheno pseudonym

2. Has the master data sheet not been printed out when creating it?

- call the funtion "neuer Patient" in secuTrial

- enter the IDATs of the study participnat data exactly like at the first input

- click "Weiter"

- the study participant will be recognized

Under "Druckansicht der Personendaten des Teilnehmers" you can print out the master data sheet.

Answered by: Independent Trusted Third Party (TTP)

The link for printing the personally identifiable information (IDAT) in secuTrial® is not displayed.

The browser may automatically scroll down when loading a page. If you cannot see everything, please scroll up / down the page using the vertical scrollbar on the right.

Answered by: Data Handling unit

How may I communicate a change of my IP address (Internet Protocol address)?

Please submit a new fully filled in client certificate request (Request for Issuance of Client Certificates) providing the new IP address. FAQ entry “How do I locate my IP address?” provides information on how to locate your IP address. Please submit the request as PDF attachment by email. Please provide the reason for change in the email.

Answered by: Independent Trusted Third Party (TTP)

An error message referring to the client certificate, is displayed on the screen (e.g. no authorization, client certificate invalid).

This error message can have several causes. Please follow the steps below successive.

  1. Carry out the authentication test after closing and reopening the browser. If the problem persists, proceed with step 2.
    a
  2. Check if your browser supports TLS 1.2 by opening the following link: browser-test.med.uni-greifswald.de
    • If the following or a similar message is displayed with a red background, the browser does not support the necessary encoding. In this case update your browser or use another one.
      aaaaaBrowser unterstützt TLS 1.2 nicht
    • If the following message is displayed on a green background, your browser does support TLS 1.2. Please continue with the next step.


      aaaaa
      a
  3. Compare the IP address which is shown in step 2 with the details on the client certificate which you sent to the TTP.
  4. Was the client certificate installed in the browser you use? See: Wie finde ich heraus ob ein Client-Zertifikat im Browser installiert ist?
    • If the certificate is not displayed, it is not installed. Instructions you find here.
    • If the certificate is not displayed, send an e-mail with the following information to the TTP support:
      • Precise the description of the issue
      • What has been done so far to manage the issue?
      • What has been done before the problem occured?

Answered by: Independent Trusted Third Party (TTP)

The client certificate cannot be installed, because …

… the error message “Passwort falsch” (Wrong password) appears.

  • Please compare your password with an employee of the Independent Trusted Third Party support. You can find contact persons here.

… the client certificate file is not displayed during installation.

  • Please show all files when selecting the file type. Please also refer to “The client certificate file is not displayed.”

Answered by: Independent Trusted Third Party (TTP)

When do I to submit a client certificate request?

A client certificate (CT) request must always be submitted for a PC. Furthermore, each user of a PC must submit a request, even if several persons use the same PC. In addition, client certificates must also be requested for new studies, even if the centre is already participating in another study. In the latter case, the TTP will review the existing client certificate and activate it for another study.

Answered by: Independent Trusted Third Party (TTP)

How do I locate my IP address (Internet Protocol address)?

Please visit site TLS 1.2 Browser Test to locate your IP address. Your IP address is displayed in the coloured rectangle.

Answered by: Independent Trusted Third Party (TTP)

May I enter myself as the requester for a client certificate request even though I am not authorised?

Yes, you may. However, you must also provide an authorised person with the client certificate request and have her/him sign it.

Answered by: Independent Trusted Third Party (TTP)

How many PCs may I specify in a client certificate request?

You may specify up to 5 PCs in a request. However, please note that we will verify the requirements for each individual PC (to be found in the “Information Sheet for Client Certificate and secuTrial ").

Answered by: Independent Trusted Third Party (TTP)

How many studies may I specify in a client certificate request?

You may specify up to 3 studies in a request. However, please note that we will verify the requirements for each individual PC (to be found in the “Information Sheet for Client Certificate and secuTrial ").

Answered by: Independent Trusted Third Party (TTP)

May several IPs (Internet Protocols) be provided in a client certificate request?

The IP address must be stated for each PC for which a client certificate is requested. This means that up to 5 IP addresses may be provided in a request.

Please refer to FAQ entry “How do I locate my IP address?” for information on how to locate your IP address.

Answered by: Independent Trusted Third Party (TTP)

Can I only see study participants who are included at my study site?

You can only see study participants who are registered at your study site. For further information please contact:

Datenhaltung des DZHK

Universitätsmedizin Göttingen

Institut für Medizinische Informatik

Robert-Koch-Straße 40

37099 Göttingen

Phone: 0551/39 13175

Fax: 0551/39 22493

Email: dzhk.support@med.uni-goettingen.de

Answered by: Independent Trusted Third Party (TTP)

May several users use the same client certificate on the same computer?

Following submission of a request (Request for Issuance of Client Certificates) and approval by the Independent Trusted Third Party, several users may use the same client certificate on the same computer. However, please note that the client certificate must be installed separately for each individual user.

More detailed information is available in the Information Sheet for Client Certificate and secuTrial.

Answered by: Independent Trusted Third Party (TTP)

I received a new PC with the same name and the same IP address (Internet Protocol address). May I continue using the former client certificate?

In this case, you may continue using the client certificate formerly provided to you.

Answered by: Independent Trusted Third Party (TTP)

May I re-request the password for a client certificate?

Requesters may re-request the password at any time.

Answered by: Independent Trusted Third Party (TTP)

The client certificate file is not displayed.

  • Save the client certificate file form your email there, where you can rediscover it easily. During the installation, navigate to this place.
  • Discover all file types during the installation of the client certificate.

Answered by: Independent Trusted Third Party (TTP)

May the client certificate also be used on an Apple PC / notebook?

As the client certificate is independent of the operating system, it may also be used on an Apple PC / notebook. However, please check prior to submitting the request that your browser supports TLS 1.2. The test is available here.

Answered by: Independent Trusted Third Party (TTP)

Is the test version of secuTrial study specific?

As every study needs an individual informed consent and eCRF's, the test version of secuTrial is study specific.

Answered by: Independent Trusted Third Party (TTP)

The client certificate cannot be imported into Firefox. The error message “The PKCS #12 operation failed for unknown reasons.” is displayed.

The Firefox database containing the client certificates is probably damaged. Please proceed as follows (you will require admin permissions):

  • Please navigate to directory “C:\Users\[USERNAME]\AppData\Roaming\Mozilla\Firefox\Profiles\XXXXXXXX.default” (Windows 7).
  • This directory will contain a file named “cert8.db.”
  • Rename it to “cert8.db_bak.”
  • Close the browser and reopen it.

Answered by: Independent Trusted Third Party (TTP)

Is it mandatory to complete an approval protocol for the first enrolment of a study participant at the study centre?

The approval protocol is supposed to be used for the review of the technical and content accuracy of the forms of the Independent Trusted Third Party (TTP forms) by the main study centre and, if applicable, to communicate necessary corrections and improvements. For this reason, only the main study centre must complete an approvaThe approval protocol is supposed to be used for the review of the technical and content accuracy of the forms of the Independent Trusted Third Party (TTP forms) by the main study centre and, if applicable, to communicate necessary corrections and improvements. For this reason, only the main study centre must complete an approval protocol prior to the beginning of a new study and in case of changes to the informed consent version (IC versions).

Answered by: Independent Trusted Third Party (TTP)

I have a question concerning the samples set.

For questions relating to the requirement, the dispatch and the biobanking samples set, please contact:

DZHK-Geschäftsstelle

Julia Hoffmann

Oudenarder Straße 16

13347 Berlin

Gruppe Klinische Forschung

Phone: 030/3465 529 03

Fax: 030/3465 529 99

Email: clinicalstudies@dzhk.de

Contact details you also find in the document "DZHK contacts" on the DZHK website.

Answered by: Independent Trusted Third Party (TTP)

Whom may I contact regarding the implementation of the electronic Case Report Forms (eCRFs) for my study?

Implementation of eCRFs is performed by the Data Handling unit in Göttingen. Please send your request by email to dzhk.support(at)med.uni-goettingen.de.

Answered by: Data Handling unit

When should I contact the Data Handling unit regarding the implementation of the electronic Case Report Forms (eCRFs)?

From experience, implementing the eCRFs according to client requirements including testing and validation will take several weeks. We thus recommend contacting the Data Handling unit as soon as possible after receipt of the notice of approval.

Answered by: Data Handling unit

Which languages may be used in the electronic Case Report Form (eCRF)?

Currently, we are offering implementation of the eCRF in German or English. You may switch freely between these two languages. You may even mix both languages (form A in German, form B in English). However, implementing a form in multiple languages at the same time (form A in German and in English) is excluded.

Answered by: Data Handling unit

Will the software used support randomisation?

Yes, the software product used by the Data Handling unit supports different randomisation algorithms. You may also perform external randomisation in advance and then import it into the software product as a list. Please clarify the details in cooperation with your statistician and your competent contact person at the Data Handling unit.

Answered by: Data Handling unit

Was the procurement of the electrocardiograph (ECG) (Cardiovit AT-102 plus, company Schiller) mandatory for DZHK institutions in the scope of the 2015 investment program?

Yes, unless the institution already owned the Cardiovit AT-102 plus.

[Resource: Funding guideline and request template for the 2015 investment program]

Answered by: DZHK Main Office (Alexandra Bayrak)

May this electrocardiograph (ECG) be used for DZHK studies if it is already available at the institution?

Yes.

[Resource: Funding guideline and request template for the 2015 investment program]

Answered by: DZHK Main Office (Alexandra Bayrak)

Is it mandatory to use the electrocardiograph (ECG) (Cardiovit AT-102 plus, company Schiller) for patient enrolment in the scope of DZHK studies?

Yes.

[Resource: Funding guideline and request template for the 2015 investment program]

Answered by: DZHK Main Office (Alexandra Bayrak)

From when must / should the electrocardiographs (ECGs) (Cardiovit AT-102 plus, company Schiller) be used for recruitment in the scope of DZHK studies?

As soon as they are ready to use, i.e. after connection to the institution's local network or Hospital Information System (HIS) has been established by company Schiller at the latest.

Answered by: DZHK Main Office (Alexandra Bayrak)

What is the role of the DZHK regarding the ethical aspects of my study?

The DZHK provides a clinical-scientific infrastructure for studies that require a complex system for data storage at different locations as well as standardised biobanking. These components must be appropriately illustrated in the ethics documents (primarily patient information sheet and informed consent form, but also in the study protocol).

The content information of the informed consent form needs to be available in a specified format so that the Independent Trusted Third Party (TTP) of the DZHK may process it. The Ethics Project is managing this technical “translation” in close cooperation with the TTP.

Additionally, the ethics documents are designed in compliance with future DZHK Use and Access Policy processes.

Therefore, please contact the DZHK Ethics Project (at the Helmholtz-Zentrum München) early if you want to start preparing the documents for the DZHK study.

Answered by: Ethics Project

I have no experience with ethics-relevant aspects. Where can I obtain information and who can help me?

The Ethics Concept of the Clinical Research Department 2.0 explains the basics of the aspects to be respected. Individual relevant process steps are provided in the Checklist.

The DZHK Ethics Project was established to support studies with this. It is useful to contact the Ethics Project prior to preparing the ethics documents to obtain explanations on the necessary steps and to receive service tailored to your project. However, it is mandatory to have patient documents reviewed by the Ethics Project for compatibility with the clinical-scientific infrastructure before submission to the Ethics Committee(s).

Answered by: Ethics Project

How must I illustrate the DZHK’s scientific infrastructure including data management in my ethics documents?

Text blocks are available in the “Muster für Patienteninformation und Einwilligung” (Master Patient Information Sheet and Informed Consent Form) of the Ethics concept of the Clinical Research Department 2.0 , and you may, as is recommended, obtain advice from the Ethics Project.

Answered by: Ethics Project

When must I prepare the ethics documents for my study?

The Flowchart provides information on timing aspects, whereas the Checklist lists all necessary process steps.

Answered by: Ethics Project

Am I required to contact the DZHK Ethics Project?

Using the service is mandatory for DZHK studies. However, the scope of service may vary significantly depending on the study.

The following are considered service:

  • Review and annotation of the patient information sheet and informed consent form by the Ethics Project prior to submission to the ethics committee(s) to ensure appropriate illustration of the clinical-scientific infrastructure.

To support the smooth processing at the DZHK, the studies are also requested to collaborate with the Ethics Project as follows:

  • Provide the finally submitted patient documents
  • Provide all votes of contacted ethics committees
  • Consult the Project in case of changes to the content of the infrastructure due to conditions or revisions
  • Provide all patient documents in-use

The Project furthermore offers counselling and diagrams regarding illustration of internal DZHK processes as well as more comprehensive service for the above-mentioned tasks, allowing for study-specific modifications as well.

Answered by: Ethics Project

Which documents is the DZHK referring to as ethics documents?

More specifically, ethics documents are patient information sheets and informed consent forms. However, it is useful to have the Ethics Project review or co-prepare all documents that are submitted to the ethics committee(s) and that are referring to the clinical-scientific infrastructure , e.g. the study protocol or the documents on data management or biobanking to be submitted to the ethics committee, as well as specific questionnaires and similar.

Beantwortet durch: Ethik-Projekt

How do I manage the versioning of the ethics documents of my multicentre study?

All changes, whether regarding content or form, should be discussed with the Ethics Project in principal. At present, the documents in the electronic version of the Trusted Third Party may only be viewed study-specifically and not site-specifically.

Answered by: Ethics Project

Who submits the documents to the ethics committee(s)?

Submission is the responsibility of the chief investigator or her/his designees. The Ethics Project acts as a counsellor and will directly contact the competent ethics committee(s) only in consultation with the study management.

Answered by: Ethics Project

What do I do in case my ethics committee does not acknowledge the data management within the scope of the DZHK’s clinical-scientific infrastructure?

In this case, it is useful to directly contact the Ethics Project and to solve this issue in a joint effort.

Answered by: Ethics Project

Are all biosamples that are collected within the scope of a DZHK study subject to the DZHK Use and Access Policy?

Yes, all biological materials that are collected and stored as DZHK “basic” material or as study-specific biological material are subject to the Use and Access Policy of the DZHK. Only material collected for routine laboratory analysis is excluded.

Answered by: DZHK Main Office (Julia Hoffmann)

What is the difference between DZHK “basic” biobanking and study-specific biobanking?

Provided the subject consents, all studies primarily funded by the DZHK are required to collect the DZHK “basic” biobanking set from each subject enrolled in a German study centre at point 0 (i.e. at baseline prior to any intervention):

Ownership and right of use of these biological materials are independent of the individual study and belong to the DZHK e. V.. The aim is to build a large collection of high-quality, well-documented and standardised biological materials with long-term availability that may be provided to the DZHK-internal and external cardiovascular research community for future research projects beyond the scope of a single study (in compliance with the DZHK Use and Access Policy and GCP regulations).

Where intended within the scope of the research purpose of the individual study or where study-related research beyond the distinct research purpose is involved, collection for the purpose of study-related DZHK biobanking is possible. Study management is responsible for planning time(s) and concrete set composition. The rights of use initially belong to the study management for up to 2 years from study completion, and their use is solely subject to a notification at the Use & Access Committee (U&A Committee, Use and Access Policy § 4 (5)). After that period, the rights of use of this biological material are transferred to the DZHK e. V. analogous to the biological material for the DZHK “basic” biobanking.

Answered by: DZHK Main Office (Julia Hoffmann)

 

 

Am I required to perform DZHK “basic” biobanking within the scope of my study?

Provided the subject consents, all studies primarily funded by the DZHK are required to collect a distinctly specified so-called DZHK “basic” biobanking set from each subject enrolled in a German study centre at point 0 (i.e. at baseline prior to any intervention) for creating a large collection of high-quality, well-documented and standardised biological materials with long-term availability.

Answered by: DZHK Main Office (Julia Hoffmann)

Who will have access to the biosamples collected within the scope of DZHK studies?

Any scientist may request the use of the DZHK “basic” material in accordance with the regulations specified in the DZHK Use and Access Policy and executed by the Use & Access Committee. Only the chief investigator will have access to the study material during the blocking period and she/he must notify the DZHK of any use (abbreviated procedure).

Answered by: DZHK Main Office (Julia Hoffmann)

What are the regulations on the details on revocation by a patient regarding biological material?

Each patient may revoke her/his consent on the use of her/his biological material, and the remaining biological material will then be destroyed. This process will be executed by the Trusted Third Party.

Answered by: DZHK Main Office (Julia Hoffmann)

It seems that biological material will even be used beyond the 10-year archival period. Will the electronic consent management system of the DZHK’s Independent Trusted Third Party (TTP) suffice concerning this or will the archival period, e.g. for the informed consents, need to be extended and, if so, for how long?

The “archival period” is specified in the cooperation agreement between the ZDM and the DZHK. In case this cooperation agreement with the TTP is terminated early unexpectedly, the data will be transferred from the TTP to the DZHK. They will continue to maintain the consent information for the DZHK studies in a suitable manner and within the scope of a successor solution.

Answered by: DZHK Main Office (Julia Hoffmann)

What is a “DZHK study”?

If at least 50 % of the expenses / costs eligible for sponsorship are covered by the DZHK e. V., it is a “DZHK study.” In this case, use of the DZHK’s clinical-scientific infrastructure and use of the DZHK Use and Access Policy as well as the implementation of the specifications from the DZHK internal harmonisation process (basic data set, basic biobanking, SOPs, etc.) is mandatory.

Answered by: DZHK Main Office (Julia Hoffmann)

Applicability of SOPs – If the DZHK published new versions of clinical SOPs, will the studies automatically switch the applicable versions?

No. Every study management will decide on which version to use and will have the decision documented in the eCRF. There is no automatic switching. Continuity is also necessary as some ethics committees have accepted the use of a specific SOP version. 

Answered by: DZHK Main Office

How to sign in at DZHK-LIMS?

No user name?

Email to: dzhk-lims(at)uni-greifswald.de

No password / forgotten?

Use link Passwortwiederherstellung

Productive system:

https://dzhk-lims.med.uni-greifswald.de/centraxx/

Education system:

https://dzhk-lims-test.med.uni-greifswald.de/centraxx/

 

Answered by: LIMS operator

 

 

 

 

How to get to the workflow overview at DZHK-LIMS?

Click workflow and then workflow tasks.

Answered by: LIMS operator

How to start a workflow at DZHK-LIMS?

Click workflow in the group inbox and then at the right site.

Answered by: LIMS operator

How to start the documentation of biomaterial extraction?

Start the workflow at the workflow tasks. Then insert LIMSPSN and select study.

Answered by: LIMS operator

Which sets do I have to choose?

At first visit choose the DZHK basic set.

If there is a study specific set also choose it.

Answered by: LIMS operator

In a study with various visits where can I indicate to which visit the biosamples belong to?

Fill out the field Visiten-Nr.

Answered by: LIMS operator

What do I do, if I cannot fill a test tube?

If you cannot fill the tube or the replacement tube, set the volume of the tube to 0 ml.

Answered by: LIMS operator

Where do I find my freezers / biobanks?

Click administration and then warehouse management.

Answered by: LIMS operator

How to store a rack in a freezer?

Choose the rack in the warehouse management and pull it to the desired storage location. If necesarry specify the position.

 

Answered by: LIMS operator  

How to create a screenshot?

Often it is helpful for the support to get a screenshot of the errors or the displayed error message. At the following website the creation of a screenshot for windows, Mac and iOS is explained: www.take-a-screenshot.org/de/.

Then, you can copy and send the saved image via email to the TTP.

Answered by: Independent Trusted Third Party (TTP)