Description of entry fields


The following table lists the parameters that are collected in the German Clinical Trials Register together with the characteristics of each parameter. The German Clinical Trials Register collects all data that are defined in the WHO dataset and a few additional items.

Parameter Characteristics/Entry
Title [Free text]
Trial Acronym [Free text]
URL of the trial [Free text]
Brief Summary in Lay Language [Free text]
Brief Summary in Scientific Language [Free text]
Keywords [Free text]
please list keywords comma separated
DRKS ID automatic
Date of Registration in DRKS automatic
Date of Registration in Partner Registry or other Primary Registry [Date]
Investigator Sponsored/Initiated Trial (IST/IIT)
  • Yes
  • No
Date of leading Ethics Committee Application [Date]
Date of leading Ethics Committee Approval [Date]
Approval of the Ethics Committee
  • Approved
  • Not approved
  • No approval required according to EC
  • Pending/not yet approved
  • Withdrawn
(leading) Ethics Committee-Number [Free text] Number
[List with ethics committees] to select
[Free text] to be entered only if "other" ethics committee
UTN (Universal Trial Number) [Number]
EudraCT-Number [Number]
EUDAMED-Number [Number]
Primary Registry-ID [Number] und [Free text] Name of registry
Partner Registry-ID [Number] und [Free text] Name of registry
Other Secondary-ID [Type] to select
  • Primary Registry-ID
  • Partner Registry-ID
  • Other Secondary-ID
  • Sponsor-ID
  • BfArM-No.
  • PEI-No.
[Free text] Name of sponsor/name of registry/ID name
Health Condition or Problem studied
  • ICD 10
  • MedDRA
  • Free text
  • Other
and [Free text] for free text or code, if not ICD 10
Other Health Condition or Problem studied See Health Condition or Problem studied
Intervention Arm 1 [Free text]
Intervention Arm 2 [Free text]
Further Intervention Arms [Free text]
Study Type
  • Interventional
  • Non-interventional
Study Type Non-interventional
  • Observational study
  • Epidemiological study
  • Other
Allocation
  • Single arm study
  • Non-randomized controlled trial
  • Randomized controlled trial
  • Other
Blinding
  • Open (masking not used)
  • blinded
Who is blinded?
  • Patient/subject
  • Investigator/therapist
  • Caregiver
  • Assessor
  • Data analyst
Control
  • Uncontrolled/Single arm
  • Placebo
  • Active control (effective treatment of control group)
  • Historical
  • Control group receives no treatment
  • Other
Purpose
  • Treatment
  • Prevention
  • Diagnostic
  • Prognosis
  • Supportive care
  • Screening
  • Health care system
  • Basic research/physiological study
  • Pharmacogenetics
  • Pharmacogenomics
  • Health economics
  • Other
Assignment
  • Single (group)
  • Parallel
  • Crossover
  • Factorial
  • Other
Phase
  • N/A
  • 0
  • I
  • I-II
  • II
  • IIa
  • IIb
  • II-III
  • III
  • IIIa
  • IIIb
  • IV
Off-label Drug use
  • Yes
  • No
  • N/A
Primary Outcome [Free text]
Secondary Outcome [Free text]
Countries of Recruitment [select list]
Locations of Recruitment [select list] Type of affiliation
[select list] City [or free text]
[free text] Affiliation
(Anticipated or Actual) Date of First Enrollment [Date]
Planned/Actual
  • Actual
  • Planned
Target Sample Size [Number]
Monocenter/Multicenter trial
  • Monocenter trial
  • Multicenter trial
National/International
  • National
  • International
Inclusion Criterion Gender
  • Male
  • Female
  • Both, male and female
Inclusion Criterion Minimum Age [Number] and [time unit] to select
  • Years
  • Months
  • Weeks
  • Days
  • Weeks of pregnancy
  • no minimum age
Inclusion Criterion Maximum Age [Number] and [time unit] to select
  • Years
  • Months
  • Weeks
  • Days
  • Weeks of pregnancy
  • no maximum age
Inclusion Criteria [Free text]
Exclusion Criteria [Free text]
Recruitment Status
  • Recruiting planned
  • Recruiting ongoing
  • Enrolling by invitation
  • Recruiting suspended on temporary hold
  • Recruiting complete, follow-up continuing
  • Recruiting complete, follow-up complete
  • Recruiting stopped after recruiting started
  • Recruiting withdrawn before recruiting started
If "Recruiting stopped after recruiting started" or "Recruiting withdrawn before recruiting started", please state a reason
  • Lack of funding
  • Competent authority requirement
  • Leading staff member change
  • Insufficient recruiting
  • Not approved
  • Other
If "Other" Reason for Recruiting Stop please specify [Free text]
Study Closing (LPLV) [Date]
Number of Participants in Germany after Recruiting complete [Number]
Total Number of Participants (all Sites worldwide) after Recruiting complete [Number]
Primary Sponsor [Address]
Title
Academic title
First name
Last name
Affiliation
Address
Postal code
City
Country
Telephone
FAX
E-mail address
URL
Contact for Scientific Queries [Address]
Contact for Public Queries [Address]
Other Address [Type] to select and [Address]
Source 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)
[Address]
Other Source of Monetary or Material Support See Source of Monetary or Material Support
Trial Publications, Results and other Documents Please select type
  • Paper
  • Abstract
  • Results
  • other documents
  • Background literature
Documents can be submitted as
  • [Free text] for bibliographic reference
  • [Upload] and [Free text] for description of document
  • [URL] and [Free text] for description of document

Last Modified: 12-06-2016