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Please scroll down to find the relevant field
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ClinicalTrials.gov identifier:
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If your trial is also registered on the ClinicalTrials.gov website, please enter the identifier assigned to your trial in the format NCTXXXXXXXX. Please leave blank if not applicable.
Field limited to NCT + 8 digits.
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EudraCT number:
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If your trial also has a EudraCT number, please enter it. The format is YYYY-123456-78. Please leave blank if not applicable.
Field limited to YYYY-123456-78.
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Protocol/serial number:
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The number given to the trial by the funder or sponsor. If you have registered your trial in any other register apart from ClinicalTrials.gov (see above), then please enter the register ID here. Please type N/A if not known.
Field limited to 200 characters.
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Public title:
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This should be the brief/layperson title. Please ensure that this title has enough information so that the public easily understands the main aim of the trial. Please note there is a character limit on this field; please keep information concise.
Field limited to 1000 characters.
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Scientific title:
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This should be the scientific title of the trial, usually used for ethics approval or grant approval. This title should be in the PICO format (i.e., the scientific title should hold information on the Participants, Intervention and Comparison groups, and the Outcomes of the trial). Please note there is a character limit on this field; please keep information concise.
Field limited to 1000 characters.
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Acronym (if available):
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Please enter the trial acronym if available. This should normally be a word formed from the letters of the words in the trial title; please type N/A if there is no acronym.
Field limited to 200 characters.
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Study hypothesis:
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The principal questions or hypotheses addressed by the project. The data entered here should be as specific as the research design permits. Where a hypothesis is being tested, please enter the hypothesis.
For observational trials, the data entered here should be a rationale for why the trial is taking place, if no hypotheses are available.
No field limit.
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Lay summary:
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A lay summary is the research question of a trial in laymen's terms but is not the patient information sheet. It is expected to be under or around 1000 words. It should answer the following questions: Background and study aims?, What does the study involve?, Who can take part?, When does the study take place?, Where does the study take place?, What are the risks to participants?, Who is funding the project?, Who is the main contact?. Please enter the URL of the lay summary webpage if it exists. Otherwise copy and paste your lay summary text.
No field limit.
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Ethics approval:
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Please provide details of the full name of your ethics board, the date of approval, and any reference numbers attached to this approval. If you have no ethics approval yet, then please enter details of when and with whom you plan to submit.
No field limit.
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Study design:
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Please specify whether the study is observational (giving details about the duration and type of study e.g. cross-sectional cohort study, longitudinal case-control study) or interventional (giving details about allocation, masking, control and assignment e.g. 'randomised single-blind placebo-controlled cross-over study'). Please also specify whether the trial is single-centre or multicentre. Please note there is a character limit on this field; please keep information concise.
Field limited to 200 characters.
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Countries of recruitment:
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Please select all the countries where recruitment for the trial is
expected to take place by holding down the control key and left click on
the required countries.
Pick list.
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Participants - inclusion criteria:
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Please list the principal inclusion criteria for participants. The participants in the trial can be patients, healthy volunteers, doctors, health professionals, etc. This section should also include the age and gender of participants.
No field limit.
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Participants - exclusion criteria:
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Please list the principal exclusion criteria for participants. The participants in the trial can be patients, healthy volunteers, doctors, health professionals, etc.
No field limit.
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Patient information material:
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If you have a web-based or PDF format patient information sheet for circulation to members of the public and prospective participants, please place a link to this information here. Please note that we can only accept URLs, as space is limited.
Field limited to 500 characters.
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Target number of participants:
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The target total recruitment of participants for the trial (across all arms and all sites if a multicentre trial).
Field limited to 200 characters.
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Anticipated start date
(dd/mm/yyyy):
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Please give the anticipated start date for the trial in the format dd/mm/yyyy. We would usually expect the start date to be the start of participant recruitment.
Date format.
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Anticipated end date
(dd/mm/yyyy):
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Please give the anticipated end date for the trial in the format dd/mm/yyyy. We would expect the end date to be either the end of participant recruitment, or the end of the trial follow-up period.
Date format.
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Disease/condition/study domain:
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Please provide a short description of the disease (one or two words), condition or healthcare domain being studied. If you would like to add more information on the disease being studied, then this information can be placed in the hypothesis section. Please note there is a character limit on this field; please keep information concise.
Field limited to 1000 characters.
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Interventions:
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For an interventional trial:
Enter the specific names of the interventions and the comparator/controls being studied. If the intervention consists of several separate treatments, please list them all. If an active control is used, be sure to enter in the name of this control, or enter "placebo" or "no treatment" as applicable. For each intervention, describe other intervention details as applicable (drug name [generic], dose, duration, frequency, mode of administration, etc).
For an observational trial:
Please provide a brief summary of your methodology, providing details of the tests that will be run, or any other pertinent information.
For all treatment arms, whether interventional or observational, please provide the total duration of treatment, and the total duration of follow-up.
No field limit.
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Primary outcome measure(s):
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Enter all primary outcome measures in the trial as well as the method used to measure the outcome and any pre-specified timepoint(s) of primary interest. Be as specific as possible with the measure used e.g., Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, one month and six months, as opposed to just "pain".
No field limit.
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Secondary outcome measure(s):
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Enter the key secondary outcome measures in the trial as well as the method used to measure the outcome and any pre-specified timepoint(s) of secondary interest. Be as specific as possible with the measure used e.g., Pain, measured using the Visual Analogue Scale (VAS) score (0 = no pain, 10 = unbearable pain) at baseline, one month and six months, as opposed to just "pain".
No field limit.
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Trial website:
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If available, please give the URL of the trial website in the format http://www.trialwebsite.com.
Field limited to 128 characters.
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Publications:
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If applicable, please list all publications directly reporting on the protocol or results of the trial. If possible, please give the citation of the publication and the URL in the format http://www.publication.com (e.g. in PubMed or the online version of the journal).
No field limit.
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Sources of funding (plus reference numbers):
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Please list all known funding sources and any reference numbers given to the trial by each funding agency. If the trial is internally funded by the organisation where the lead principal investigator carries out the research, please give the name of this organisation.
No field limit.
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Sponsor details:
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Please enter the name and contact details of the organisation acting as sponsor for this trial. Please note that we can only fit the information for one sponsor in this section. If you have a joint or secondary sponsor, then please enter the contact details of this second sponsor in the interventions section of the trial record under the title ‘Joint/Secondary sponsor details’.
Field limited by format.
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Sponsor privacy level:
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Sponsors may request that the telephone, fax and email are not displayed in the public trial record.
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Contact details:
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Please enter the name and contact details of the Principal Investigator (PI) of the trial. Please note that we can only fit the information for one contact in this section. If you have a joint PI or separate scientific and public contacts, then keep the public contact details in this section and add the scientific contact or joint PI details in the interventions section of the trial record under the title ‘Joint/Scientific contact details’.
Field limited by format.
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Contact privacy level:
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Trial contacts may request that the telephone, fax and email are not displayed in the public trial record.
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Where did you learn about the ISRCTN scheme?:
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Please specify the name of the organisation or medical journal that requires or recommends trial registration. If this registration is in conjunction with a submission to one of our sister company BioMed Central's journals, please enter 'Article submission to BMC' followed by the name of the BMC journal you are submitting to.
Field limited to 1000 characters.
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| Last updated on 18 December 2012 |