Frequently Asked Questions (FAQ)

Here you will find answers to frequently asked questions in the following areas:

FAQ German Online Medicine Retailer Register

Open one of the provided overviews of online medicine retailer.

  • Press the keys "Ctrl" and "F" simultaneously. The Find toolbar is now activated.
  • Type your search term or parts of it, e.g. name or location of the retailer, in the text box on the Find toolbar and press the Enter key to start the search.
  • If there are several hits for your search term, click the button "Find Previous" or "Find Next" next to the Find Toolbar.

According to the country list of the German Federal Ministry of Health (BMG)

  1. human medicine may currently be shipped to Germany from
    • Iceland
    • the Netherlands (only if also an associated retail pharmacy exists)
    • Sweden (for prescription medicine only)
    • the Czech Republic (for non-prescription medicine only)
    • the United Kingdom
  2. veterinary medicine may currently be shipped to Germany from
    • the Czech Republic (for non-prescription medicine only)
    • the United Kingdom.

Please be aware that these online medicine retailers have to act in compliance with German law. DIMDI is not a competent supervisory authority.

If the retailer you are seeking is missing in the register, there may be the following reasons for this:

  • The pharmacy holds a mail order permit, but is not yet included in the register.
  • The pharmacy does not hold a mail order permit.
  • The medicine retailer is allowed to trade, but is not yet included in the register.
  • The medicine retailer isn’t allowed to trade.

No. Please refer to the regional competent supervisory authority that has issued this mail order permit. You find it in the overviews of mail order pharmacies in the column with the heading "Für die Erlaubnis zuständige Stelle". You may also take the matter to court.

No, because the logo does not have any significance in itself!

However, in three simple steps you can reduce the risk of ordering on websites of dubious suppliers:

  1. Click
    Click on the logo: If the retailer is included in the register, a DIMDI website opens containing the retailer's register entry.
  2. Check
    Check whether the website address (URL) in the adress bar after the https:// begins with "versandhandel.dimdi.de/". Pay particular attention to the forward slash (/) after ".de".
    The lock symbol in the adress bar indicates that the web page is trustworthy (colour and design varies with different browsers). It confirms the validity of the website’s security certificate and that a secure connection is established. Check by clicking on the lock symbol and opening the certificate that you are really on a DIMDI web page.
  3. Buy
    Open the retailer's website through one of the links indicated in the register. Do not use your browser's back button and do not return to a window that may still be open.

If no register entry opens, there may be the following reasons for this:

  • The logo was incorrectly incorporated.
  • A technical fault is present. In this case, try to retrieve the register entry again later.
  • The logo is misused by a suspicious internet trader. If you suspect someone of doing so we kindly ask you to send us the information of this website to Versandhandel.
  1. Click
    Click on the logo: If the retailer is included in the register, a DIMDI website opens containing the retailer's register entry.
  2. Check
    Check whether the website address (URL) in the adress bar after the https:// begins with "versandhandel.dimdi.de/". Pay particular attention to the forward slash (/) after ".de".
    The lock symbol in the adress bar indicates that the web page is trustworthy (colour and design varies with different browsers). It confirms the validity of the website’s security certificate and that a secure connection is established. Check by clicking on the lock symbol and opening the certificate that you are really on a DIMDI web page.
  3. Buy
    Open the retailer's website through one of the links indicated in the register. Do not use your browser’s back button and do not return to a window that may still be open.

The website is not necessarily bogus. In order to check whether the logo is nevertheless legitimately displayed on the online medicine retailer’s website(s), look it up in our overview of all included online medicine retailers. Please inform us if you cannot find the retailer there either.

Other reasons why clicking on the logo does not link to a register entry:

  • The logo was incorrectly incorporated.
  • A technical fault is present. In this case, try to retrieve the register entry again later.
  • The logo is misused by a suspicious internet trader. If you suspect someone of doing so we kindly ask you to send us the information of this website to Versandhandel.

Online medicine retailer have to display the logo on their website(s). Additionally you can check whether the retailer involved is included in the German Register of Online Medicine Retailers very simply in our overview of all included online medicine retailers.

If the retailer you are seeking is missing in the register too, there may be the following reasons for this:

  • The pharmacy holds a mail order permit, but is not yet included in the register.
  • The pharmacy does not hold a mail order permit.
  • The medicine retailer is allowed to trade, but is not yet included in the register.
  • The medicine retailer isn’t allowed to trade.

No. The EU security logo exclusively shows that the retailer has an official permit for the mail order trade.

Yes. The EU security logo may only be displayed on registered websites. Furthermore, the logo is protected by copyright. The EU security logo may not be used without the consent of DIMDI. Use of the logo by retailer is fundamentally restricted to the link from the retailer’s website(s) to the register’s respective register entry at DIMDI.

No. The competent supervisory authorities that also issue the mail order permits are responsible for monitoring the retailer.

For owners of a German mail order permit:

For inclusion in the German Register of Online Medicine Retailers please refer to your regional competent supervisory authority. This authority will pass the required documents on to DIMDI. Your data will subsequently be entered at DIMDI and you will receive the information for displaying the EU-security logo on your retailer’s website(s).

For owners of a mail order permit from abroad:

Please refer to the appropriate competent authority of your country. Each EU member state provides its own national register of online medicine retailer.

FAQ Iris Institute: General Information on Iris

The download and the use of the Iris software is free, there are no licences. Except: You have to accept the download condition at the time of the download.

In ancient Greek mythology, Iris is the goddess of the rainbow and the gods’ messenger. The rainbow is the bridge that Iris travels when carrying messages from the gods to humans. It is also her duty to fetch water from Styx, the river that separates the realm of the living from the realm of the dead, whenever the gods take a solemn oath. Any god that tries to cheat will fall asleep when drinking the water, and stay asleep for a year.

We chose the name of Iris for our software because of the associations with message-bearing and bridging. The aim was to develop a common mortality coding system that could be used for coding death certificates in any language. In that sense it constitutes a bridge between the language, which is local, and the ICD mortality coding instructions, which are international. The association with the river Styx is a further bonus - and it is also the name of a previous coding software developed in France, which has now been replaced by Iris.

In the logo the rainbow is indicated by the curved lines. There are 5 lines representing the 5 countries that founded the Iris Institute.

Yes, there are interfaces in: Czech, English, French, Portuguese and Spanish.

Apart from the existing adaptations the Iris interface can be translated in any language.

You can create your own dictionary and standardizations in your language or you ask other countries if there is a dictionary available in your language.

 

You can subscribe to our newsletter to receive all relevant information on Iris, including updates.

No, fields like firstTime, EntryLevel, PswEntryOnly, PswCoder, PswHyper, PswAdmin and UserRights in the config file are not related to the maintenance password. They are used for specific adaptations of Iris.

Yes. To change the maintenance password, the user needs the present password (see Iris Reference Guide). If he knows this password, he can change it.

You can use Iris under these systems:

  • Microsoft Windows Vista, Windows 7, Windows 8, Windows 8.1 and Windows 10
  • Microsoft .Net Framework (since 4.5.2)
  • Microsoft Access 2003 or later, if no other database manager is available (it is not possible to use "Open Office" database)
  • or a robust relational database server like Oracle, MSSQL or MySQL directly
  • or any through OLEDB, parameters described on www.connectionstrings.com

Iris is independent of your browser and you can use Iris in a server environment for multiple users.

No, that is not possible. All users should use the application in the same way.

The Iris Institute no longer supports Iris versions older than version 5. The updated tables in Iris version 5 can no longer be handled by MMDS.

The structure of the unicausal tables has changed a little bit:

SENMC rule is replaced by IDMC and SENDC rule is replaced by IDDC in Iris version 5. IDMC is a new rule and it cannot be handled by MMDS. We also deleted all obsolete codes in the unicausal tables. Therefore the TABA and TABB would not work in the right way and it is not possible to produce MMDS tables for these technical reasons.

In addition, the ICD-10 updates for 2016 involve some algorithm changes which are implemented in MUSE, but not in MMDS. So the new tables and the new rules for selection of the underlying cause will not be applied in MMDS.

Please find more information about the unicausal rules at the Iris Reference Guide.

FAQ Iris Institute: Installation

You can change the path were you store the "spec" folder.

Click the tab "Tools" and select "Options". A new window should appear. Click the tab "Coding" and click on "Version". Another new window should appear. Click on "Change Path" and select your "spec" folder.

First set the location in MMDS.ini. Then start Iris and within the Tools menu choose the Options item. On the Coding tab you can set the locations of the MMDS DATA folder, Micar.exe and Acme.exe.

No, there is no registry update done by the Iris installation. It just installs files at the specified location and creates shortcuts.

Yes. The paths are supplied in the Iris.exe.config and can be defined relative to the .exe place.

FAQ Iris Institute: Database

Following the links below you will find scripts and screenshots on how to create an Oracle or MSSQL database (e.g. for dictionary, certificate, standardisation).

Qracle settings
MSSQL settings

The Iris Institute provides two different tables for the time intervals ("TimeIntervals" and "TimeIntervals_Ref").

"TimeIntervals_Ref" is using the round bracket "()" as delimiter and the "TimeInterval" table is using the paragraph "§" as delimiter for the time interval. So it depends on what you would like to use as delimiter. The round bracket is set as default. You can select the paragraph as delimiter in the options window (Tools >> Options >> User). Please tick the checkbox "use '§' as delimiter for intervals".

Yes, it's possible: [servername]; Port=[port number]

In the following example the default is 3306, but it can be any arbitrary port number.
Example: Click the "Tools" tab and select "Options". A new window should appear. Click the "Certificate database" tab or "Table database".

Select the checkbox "MySQL ADO.NET". Into the field "Server" type 'localhost;Port=3306'. Into the field "Database" type 'iris'.

The user needs permission for all the lot tables (all tables suffixed by 'Ident' or 'MedCod'):

Ident tables: SELECT, UPDATE (there is no creation or deletion of records in Ident table)
MedCod tables: SELECT, UPDATE, DELETE and CREATE (causes of death can be deleted and / or created during the coding process).

 

If you use Microsoft Access 2007 or higher, then you have to change the provider string in the "Options" (Click the tab "Tools" and select "Options").

For example if you want to change the standard settings from Microsoft Office Version 2003 to Version 2010, you have to change the provider from 'Microsoft.Jet.OLEDB.4.0' to 'Microsoft.ACE.OLEDB.12.0'.

When you use the link below, you will find the connection strings for each Microsoft Office version. You will find the link below as well at your Options tool for Tables database and Certificate database.

As Iris is developing rapidly, you should consult the table definition in the Access databases supplied by Iris. The Iris Reference Guide is updated with every new version of Iris.

Yes, Iris detects access conflicts and warns the coder if the record has been changed by another user. This should be avoided because it can result in data loss. The same warning occurs when using Iris on a write-protected database.

We use Windows or user authentication. Iris doesn't manage application roles at the moment. This is something that could be implemented later if there is a strong need.

"U" stands for Unknown and "N" for No. These values appear in the certificate database in the Ident table in columns like AutopsyRequested, AutopsyUsed, RecentSurgery, Stillbirth and MultiplePregnancy. These text fields are optional.

FAQ Iris Institute: Batch Processing and Interactive Coding

No, it is not possible to run Iris on other programs. There is no specific program to process batch coding. However, Iris can be launched two times on the same machine: One, for instance, can process a lot in batch, while the other can be used to process another lot in interactive mode. Note that the two lots must be different, otherwise access conflicts may occur. This way the coders do not lose time for batch processing before they start coding.

Iris cannot be launched by another process and the Iris executable file doesn't accept parameters. All parameters needed for a specific implementation are defined in Iris using the options item within the Tools menu.

Please check the "Disable logging" settings option. Click the tab "Tools" and select "Options". A new window should appear. Then click the tab "General". The checkbox "Disable logging" should not be ticked.

MUSE can handle a maximum of 12 codes in one line. Ideally, the death certificate contains only one term in each line. Usually, not more than 12 codes are needed.

There are five options to solve this situation:

  1. If the diagnosis text was written correctly, you can add this diagnosis text to your dictionary. For this you can use the dictionary tool, but the text should be added by a supervisor or another person who has the rights to add entries to the dictionary.
  2. You could change the diagnosis text at the Iris interface, if it was a misspelling or a synonym is available in the dictionary. Please note that in some countries it is not allowed to change the diagnoses text. So at first please check your legal situation.
  3. You could add the code manually behind the diagnosis text to the field "ICD-10 codes". For this, please click first on the tick box, then you can add the code.
  4. If the diagnosis text was not spelled correctly and this occurs frequently, you can add this diagnosis text to your standardization table. For this you can use the standardization tool, but it should be added by a supervisor or another person who has the rights to add entries to the standardization table. Be careful: adding entries to the standardization tool might have impact on other terms spelled almost like the text you would like to change. Make sure to test your change before using it in routine settings.
  5. You could also use the "Multiple codes browser" to add the correct codes for the diagnosis text. Click on the MC button and add the correct codes. This tool should be used only by experience users.

FAQ German Clinical Trials Register

No. In Germany, in contrast to other countries like e.g. the US, there is no legal requirement to register clinical trials. Various groups and organisations like research funding institutions (BMBF, DFG and other) and most of the leading medical journals (q.v. "What is ICMJE?") demand the registration of clinical trials as prerequisite for funding or publication and thus create a certain pressure.

The DRKS is the German WHO primary registry and is competent for the registration of all clinical trials conducted in Germany. Our aim is to offer a complete topical overview of all trials conducted in Germany and thus providing a contact point for clinical trials in Germany.
The DRKS is a non-profit organization and is located at the German Institute of Medical Documentation and Information (DIMDI). DIMDI is a governmental institution within the scope of the Federal Ministry of Health (BMG).

The objectives of the DRKS are:

  • to offer a central point of contact for information on clinical trials in Germany.
  • to provide a complete, up-to-date overview of all patient-oriented clinical trials conducted in Germany.
  • to provide all users with easy and free access to the registry.
  • to inform the public in German and English.
  • to provide the basis for scientific statements on the type and number of studies conducted in Germany.
  • to support sponsors in the planning of clinical trials.
  • to promote the quality of clinical research in Germany through the transparency of study data.
  • to provide the necessary information and to create the conditions for the cooperation of different clinics and working groups.
  • To support ethics committees and authorities in fulfilling their assessment and supervisory tasks.
  • to enable the ICMJE-compliant registration of planned clinical trials in Germany.

Both searching for clinical trials and registering new trials is free of charge. The entry mask is available in both German and English and was designed in a very user-friendly way. Most of the parameters can be filled in with drop-down menus using standards, catalogues and (internationally) used codes like the identification key ICD-10. These standardisations make entering data and data exchange easier and are also the prerequisite for automatic plausibility and validity checks and descriptive statistical evaluation. Possible answers are recorded in both English and German to obtain a bilingual registry. We tried to avoid free text slots as much as possible.
Furthermore, participation in trials is facilitated, as patients and their attending physicians can find information on on-going trials in the DRKS.

Clinical trial registries increase the transparency in clinical research because they provide public access to trial data. They serve as a source of information for patients and support the expert audience in the planning of clinical trials e.g. by helping to avoid redundant trials.

People conducting clinical trials have the responsibility towards patients, sponsors, colleagues and the public in general to publish their outcomes. A delayed or completely missed publication of a trial which had unwanted or supposedly uninteresting outcomes can lead to a severe bias. Possible consequences are overemphasis of the benefits of a therapy and at the same time disregard of potential risks. Complete registries of clinical trials are one important component to avoid under-reporting as they prove the existence of a trial in form of a "birth certificate" and thus prevent the disappearance of a trial.
The World Medical Association demands in the Declaration of Helsinki (version 2008) in paragraph 19: "Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject."

The DRKS is the only study registry for Germany recognised by the WHO; the DRKS collects data on all studies in German and English. Patients and other interested laypersons can better use and understand entries in their national language. Information provided in German can thus improve recruitment in a study, as patients can more easily find information about the study. By registering a study in both languages in the DRKS, the greatest possible transparency for the German public regarding clinical trials is achieved.

Studies that are already registered in ClincialTrials.gov can be transferred to the DRKS system through the DRKS data management if desired. In the DRKS, you then only have to add a few German free text fields, which results in little additional effort. If you would like this procedure for a study you have registered in ClincialTrials.gov, please contact the DRKS staff.

Criteria for admission to the DRKS:

  • The study must deal with a health issue, e.g. disease treatment, therapy monitoring, examination of risk factors, etc.
  • The question must be as clear as possible; pure patient data collections without a clear clinical reference cannot be registered in the DRKS.
  • It must be a human study (no animal experiments etc., no pure tissue research).
  • Studies on dummies can be registered in the DRKS, because the object of study is the doctor/nurse who should learn something from the dummy doll.
  • Only individual studies can be registered in the DRKS, no reviews or meta-analyses. If you wish to register such a research project, please check whether PROSPERO could be a suitable database (www.crd.york.ac.uk).
  • Training studies (studies in which people receive training or similar, the effect of which is to be tested) can also be registered with the DRKS. However, this only applies if the trained individuals themselves directly treat patients (not necessarily as part of the study). So: Such studies on doctors, nurses etc. can be registered in the DRKS, studies on students cannot.

Worldwide, there are a lot of claims that not only interventional clinical trials should be registered but also observational and prognosis studies. The Lancet encourages the registration of all observational studies on a WHO-compliant registry (Lancet 2010; 375: 348). In the registry network of the WHO, an expansion of the registration which goes beyond the classical definition of a clinical trial (see below) is extensively discussed. The need of an observational studies register was also described in 2010 by Swaen in the Journal of Clinical Epidemiology (64 (5), p.481-486).

Therefore, we would like to invite you to register all trials (including interventional clinical trials but also observational and prognosis studies with the aim to gain knowledge on a disease or health problems of participants) at the DRKS.

If you are unsure please contact the DRKS team before registration.

In order to register a trial according to ICMJE standards, it has to be registered in a registry accepted by the ICMJE before recruiting the first participant (prospective), i.e. before the first participant signed the written consent form. All trials registered after recruiting the first participant are considered to be retrospective and are not conform to the ICMJE principles.

Please bear in mind that a trial can only be registered after routine automatic and manual checks on validity and completeness and, therefore, will not be publicly visible until after these checks. We know from experience that generally some queries have to be answered. So please plan enough time (at least several days in which you are accessible and can make necessary changes) for the registration process.

The sponsor is responsible for the registration. The task can, however, also be delegated (e.g. to the Principle Investigator/ Lead Principle Investigator).

Yes, you can also register ongoing and finished trials. However, this retrospective registration does not meet the standards of ICMJE and might not be accepted by all journals. Retrospectively registered trials are clearly marked as such in the DRKS.

No. The DRKS is the primary registry for Germany recognised by the WHO and is bound by the WHO's international standards for clinical trial registries. It stipulates that once a study has been registered, it may never be deleted.

No. Both registration and searching for trials is free.

The International Committee of Medical Journal Editors (ICMJE) is a union of the publishers of leading international medical journals which set guidelines for the publication of clinical trials. The ICMJE includes journals like JAMA, New England Journal of Medicine and The Lancet. It demands the prospective registration of clinical trials as requirement for a publication (http://www.icmje.org/publishing_10register.html). Over 700 medical journals joined this union (http://www.icmje.org/journals.html).

Yes. ICMJE accepts registration in all primary registries of the WHO network. The DRKS is accepted as primary registry for Germany by the WHO since 2008 and thus meets the requirements of the International Committee of Medical Journal Editors (ICMJE).

The "International Prospective Register for Systematic Reviews PROSPERO" is open for free registration to anyone undertaking a systematic review with a health-related outcome.

Until 30 June 2017, studies from other registers were also imported for cooperation partners. Adjustments were necessary for studies imported from ClinicalTrials. gov. You can still see an overview of these adjustments here (PDF, 9,7 kB).

If the activation link for you account does not work or if you are not able to reset your password please get in touch with the data management team (kontakt-drks@dimdi.de).