To enter and edit trials, you must register and create a personal user account. Your user name and password will give you access to the closed area of the portal. There you can enter data on your trial and request its publication. A list of all data entry fields can be found below.
For the DRKS, studies must meet the following requirements:
- The trial must address a health-related question
- It must involve human subjects
The exact criteria can be found in the FAQ "Which trials can/should be registered with the DRKS?" There you will also find instructions on how to register your trial prospectively.
Please note that JavaScript must be allowed in the DRKS application to use the closed area.
Study Submission
To register and edit studies
Login
Manual for Study- and User Registration
A detailled explanation of how to set up your user account and record your trials can be found here:
Table of Data Entry Fields
The following table lists the parameters that are collected in the German Clinical Trials Register together with the characteristics of each parameter. It also indicates which data points belong to the WHO dataset and are regularly submitted to the WHO meta registry ICTRP. The table is divided into 6 thematic areas, which are found accordingly in the DRKS application.
Study Description
| Parameter | Characteristics/Entry | WHO |
|---|
| DRKS-ID | [ID] (filled automatically) | yes |
| Date of registration in DRKS | [Date] (filled automatically) | yes |
| Type of registration | [Select List] (filled automatically)
| yes |
| Title of the study | [Free Text] | yes |
| Acronym/abbreviation of the study | [Free Text] | yes |
| URL of the study | [Free Text] | no |
| Arm 1 | [Free Text] | yes |
| Additional arms | [Free Text] | yes |
| Primary outcome | [Free Text] | yes |
| Secondary outcome | [Free Text] | yes |
| Study description in lay language | [Free Text] | no |
| Study description in scientific language | [Free Text] | no |
Health condition or problem studied
Code system | [Select List]
| yes |
| Code | [Free Text] (only, if chosen "ICD-10") | yes |
| Description | [Free Text] (only active if "Free text" is selected, otherwise the code specified in the system is entered automatically) | yes |
Other health condition or problem studied
Code system | See Health condition or problem studied | yes |
| Healthy volunteers | [Radio button]
| no |
Ethics Vote and Other IDs
| Parameter | Characteristics/Entry | WHO |
|---|
Address ethics committee
(leading)
| [Checkbox] Privacy notice (not submitted to WHO)
[Select list] Ethics Committee
[Address] (only active if "Other" is selected, otherwise the address in the system is automatically entered)
- Name ethics committee
- Street address/PO Box
- Postal code
- City
- Country
- Phone number (with country code)
- Fax number (with country code)
- Email address
- URL of the institution
| yes |
Date of ethics committee application
(leading)
| [Date] | no |
Ethics review
(leading)
| [Select List]
- Approved
- No approval required according to the EC
- Pending/not yet approved
| yes |
Date of ethics review
(leading)
| [Date] | yes |
Ethics committee number
(leading)
| [Free Text] | yes |
Approval of ethics committee
(leading)
| [File Upload] | no |
Additional vote or amendment
(leading)
| [File Upload] | no |
| Optional other ethics committees | As with lead ethics committee
- [Address] Address ethics committee
- [Select List] Ethics review
- [Date] Date of ethics review
| yes |
| No other identification numbers available | [Checkbox] | no |
| Other primary registry ID | - [Free Text] Registry number
- [Free Text] Registry name
| yes |
| UTN (Universal Trial Number) | [Free Text] ID | yes |
| EudraCT Number | [Free Text] ID | yes |
| EUDAMED Number | [Free Text] ID | yes |
| Other secondary IDs | - [Free Text] ID/number/funding number
- [Free Text] Institution name/funding institution
| yes |
Study Design
| Parameter | Characteristics/Entry | WHO |
|---|
| Purpose | [Select List]
- Treatment
- Prevention
- Diagnostics
- Prognosis
- Supportive care
- Screening
- Health care system
- Basic research/physiological study
- Pharmacogenetics
- Pharmacogenomics
- Health economics
- Other
| yes |
| Study type | [Radio Button]
- Interventional
- Non-interventional
| yes |
| If study type "Interventional": | | |
| Allocation | [Select List]
- N/A (single arm study)
- Non-randomized controlled study
- Randomized controlled study
| yes |
| Assignment | [Select List]
- Single (group)
- Parallel
- Crossover
- Factorial
- Other
| yes |
| Mechanism of allocation concealment | [Free text] | no |
| Sequence generation | [Free text] | no |
| Control | [Select List, multiple choice]
- Uncontrolled/single arm
- Placebo
- Active control (effective treatment of control group)
- Historical
- Control group receives no treatment
- Other
| yes |
| Blinding | [Radio Button]
| yes |
| Who is blinded? | [Select List, multiple choice]
- Patient/subject
- Investigator/therapist
- Caregiver
- Assessor
- Data analyst
| yes |
| Phase | [Select List]
- Not Applicable
- 0
- I
- I-II
- II
- II-III
- III
- IV
| yes |
| If study type "Non-interventional": | | |
| Retrospective/prospective | [Select List]
- Retrospective
- Prospective
- Both
| no |
| Longitudinal/cross-sectional | [Select List]
- Longitudinal study
- Cross-sectional study
| no |
| Study type non-interventional | [Checkboxes]
- Epidemiological study
- Patient registry
| no |
Recruitment Data
| Parameter | Characteristics/Entry | WHO |
|---|
| Recruitment countries | [Select List] | yes |
| Number of study centers | [Radio Button]
- Monocenter study
- Multicenter study
| no |
| Recruitment location | [Select List] Type of institution
- University medical center
- Medical center
- Doctor’s practice
- Other
[Free Text] City
[Free Text] Name of institution (only active if type of institution is not "Doctor’s practice")
| no |
| Recruitment status | [Select List]
- Recruiting planned
- Recruiting ongoing
- Enrolling by invitation
- Recruiting suspended on temporary hold
- Recruiting complete, study ongoing
- Recruiting complete, study complete
- Recruiting stopped (after recruiting started)
- Recruiting withdrawn (before recruiting started)
| yes |
| Planned study start date | [Date] | yes |
| Actual study start date | [Date] | yes |
| Planned study completion date | [Date] | yes |
| Actual study completion date | [Date] | yes |
| Target sample size | [Number] | yes |
| Final sample size | [Number] | yes |
| Reason if recruiting stopped or withdrawn | [Free text] | no |
| Sex | [Select List]
| yes |
| Minimum age | [Number]
[List] Unit
- Years
- Months
- Weeks
- Days
- Weeks of pregnancy
[Checkbox] No minimum age | yes |
| Maximum age | [Number]
[List] Unit
- Years
- Months
- Weeks
- Days
- Weeks of pregnancy
[Checkbox] No maximum age | yes |
| Additional inclusion criteria | [Free text] | yes |
| Exclusion criteria | [Free text] | yes |
Contacts
| Parameter | Characteristics/Entry | WHO |
|---|
| Primary Sponsor | [Address]
- Institution
- Academic title
- First name
- Last name
- Street address/PO Box
- Postal code
- City
- Country
- Phone number (with country code)
- Fax number (with country code)
- Email address
- URL of the institution
[Radio Button] Investigator Sponsored/Initiated Trial (IST/IIT) (not submitted to WHO)
| yes |
| Principal investigator | [Address] see "Primary Sponsor" | yes |
| Contact for scientific queries | [Checkbox] Define contact different from PI
If Checkbox active:
[Address] see "Primary Sponsor"
| yes |
| Contact for public queries | [Checkbox] Define contact different from PI
If Checkbox active:
[Address] see "Primary Sponsor"
| yes |
| Source of monetary or material support | [Checkbox] Privacy notice (not submitted to WHO)
[Address]
- Institution
- Street address/PO Box
- Postal code
- City
- Country
- Phone number (with country code)
- Fax number (with country code)
- Email address
- URL of the institution
[Select List] Type of monetary or material support
- Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Private sponsorship (foundations, study societies, etc.)
- Institutional budget, no external funding (budget of sponsor/PI)
| yes |
| Secondary sponsor (not for German studies) | [Address] see "Primary Sponsor" | yes |
| Other addresses and contacts | [Address] see "Primary Sponsor" | yes |
Study Results
| Parameter | Characteristics/Entry | WHO |
|---|
| Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form? | [Radio Button]
| yes |
| IPD Sharing Plan | [Free text] | yes |
| Study protocols | [Free text] Description
[Free text] Add link
[File upload] Attach file
| yes |
| Study abstract | see "Study protocols" | no |
| Other study documents | see "Study protocols" | no |
| Background literature | see "Study protocols" | no |
| Related DRKS studies | [Free Text] DRKS ID
[Free Text] Description
| no |
| Planned publication | [Free text] | no |
Publications/study results
Description
| see "Study protocols" | yes |
| Date of first publication of study results | [Date] | yes |
| DRKS entry published for the first time with results | [Date] (assigned by the data management) | yes |
Basic reporting/result tables
Description
| see "Study protocols" | yes |
| Brief summary of results | [Free text] | yes |
Completion Guide
Below you will find the general instructions for study registration and a completion guide per edit tab describing each data point in detail:
