Cochrane Renal Group

Prospective Trials Registration

Welcome to the Cochrane Renal Group Prospective Trial Registration pages. Trials that conform to the International Committee of Medical Journal Editors (ICMJE) definition i.e. “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause and effect relationship between a medical intervention and a health outcome” ...and have at least one prospectively assigned concurrent control or comparison group" [1,2] within the area of nephrology may be registered here.

Please note that the ICMJE recognises registration of a trial only on 5 trial registers or WHO Primary Registers. For further information about these registers, and the ICMJE trial registration policies please see their website and in particular the June 2007 Update on Trial Registration.

The registration process requires data about the study or trial to be submitted under the following headings:

  • Study title which includes an acronymn or a web site for further information
  • Lead Investigator
  • Study contact or Study coordinator,
  • Sources of funding
  • Study design
  • Study description
  • References

Once you have submitted the form, you will receive a return email containing a unique registration number, e.g. CRG00001, for your trial.

Fields with an asterisk [*] MUST be completed

Data submitted through this site is available for searching and browsing at http://www.cochrane-renal.org/dbsearch.php

Staff of the Cochrane Renal Group will be responsible for maintaining the information provided. The data provided will also be maintained on the Cochrane Renal Group's Specialised Register and published in the Cochrane Central Register of Controlled Trials (CENTRAL) on the Cochrane Library.

Please contact us at crg@chw.edu.au with any suggestions or queries you have about this registration process.

Study
* Title of study
  Enter the official scientific title of the study which includes the condition, intervention and outcome.
Acronymn or brief title
Web site adddress
Identification number (ID)
  Please provide any IDs assigned by sponsors or other parties (if available)
e.g. Study name, grant number or accession number
 
Lead Investigator
* Prefix
* Surname
* Given names
* Position
* Department
* Organisation
* Address
  Please provide the full address of the organisation you represent
i.e. Street address or PO Box number, town or city, postcode or zipcode, and country
* Email
* Phone
  Please provide full number i.e. international country dialling codes e.g. +61 2 9845 2035
* Fax
  Please provide full number i.e. international country dialling codes e.g. +61 2 9845 2035
Suffix
 
Study Contact e.g. Study Coordinator
Prefix
Surname
Given names
Position
Department
Organisation
Address
Email
Phone
Fax
 
Sources of funding
Select all sources of funding
If other, please state
Name of sponsor/s
  Please list the names of all sponsors both industry, government and non-government
e.g. National Health and Medical Research Council (NHMRC), Australia, The Drug Company
 
Ethics Approval
Does the study have ethics committee approval?
 
Study design
Type
If non-randomised, please describe
Group assignment
Blinding Patients Investigators
Outcome assessors Data analysts
Start date Proposed Actual
  This refers to the enrollment date of first participant/s.
Indicate dates using the format of month and year e.g 11/2005 or Nov 2005
Completion date Proposed Actual
  Indicate dates using the format of month and year e.g 11/2005 or Nov 2005
Is this a multi-centre study?
If Yes, select the number of centres involved
Is this a multi-national study?
If Yes, select the countries involved.
  Press Ctrl to make more than 1 selection from the countries list
 
Study description
Research question (in plain English)
Status of study: Recruitment Follow-up
  Recruitment definitions:
Not yet recruiting: participants are not yet being recruited or enrolled
Ongoing: participants are currently being recruited or enrolled
Recruitment completed: participants are no longer being recruited or enrolled
Health care condition
  Provide keywords to describe the health care condition being studied e.g. acute renal failure, renal colic, urinary tract infection
Intervention 1
  If the intervention or comparator are drugs, supply the generic name or company serial number if unregistered.
Intervention 2
  If the intervention or comparator are drugs, supply the generic name or company serial number if unregistered.
Intervention 3
  If the intervention or comparator are drugs, supply the generic name or company serial number if unregistered.
Intervention 4
  If the intervention or comparator are drugs, supply the generic name or company serial number if unregistered.
Participants (gender)
Participants (other)
Age
  Indicate the minimum and maximum age of participants; if neither, use N/A.
Total to be recruited
  Indicate the planned number of participants for enrollment
Inclusion criteria
Briefly list the key patient characteristics that determine eligibility for participation in this study e.g. pre-dialysis paients
Exclusion criteria
  Briefly list the key patient characteristics that determine exclusion of participants in this study e.g diabetes
Primary outcomes
  Enter the names of all primary outcomes as well as pre-specified timepoint(s) of primary interest;
e.g. Outcome: proportion of patients experiencing at least one episode of renal allograft rejection; Timepoints: 3 months, 12 months
Secondary outcomes
  Enter the names and timepoints for all secondary outcomes of clinical and/or scientific importance;
e.g. Outcome: all cause mortality; Timepoints: 3 months, 12 months
 
References
Please provide complete citation/s or information for any reports (published and unpublished) generated by this study
  1. De Angelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292:1363-1364. Full text
  2. De Angelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA.2005;293