Prospective Registration
Clinical trials should be registered in an acceptable public trial registry before enrolment of the first participant or at the time of first participant consent, as applicable to the study context.
Clinical Research Transparency
Clinical Trial Registration Policy
UnivColl Publications requires transparent disclosure of clinical trial registration, ethics approval, informed consent, reporting standards and study integrity information for manuscripts reporting human participant interventional health research.
Publisher Policy
A Clear Policy for Clinical Trial Registration, Ethics and Transparent Reporting
This policy applies to journal manuscripts, conference proceedings, special issues and other publication formats managed by UnivColl Publications where the submitted work reports an interventional clinical trial or health-related human participant research requiring registration, ethics oversight or formal reporting transparency.
Public Registry Record
The registration record should be publicly searchable, include sufficient study details and clearly identify the trial title, sponsor, investigators, intervention, outcomes and recruitment information.
Trial ID in Manuscript
Authors must provide the registry name, registration number, registration date and a working registry record link in the manuscript and submission form.
Ethics Approval Required
Trial registration does not replace ethics committee, institutional review board or regulatory approval. Human participant research must include appropriate approval and informed consent details.
Important: UnivColl Publications does not operate a clinical trial registry and does not provide legal,
regulatory or medical advice. Authors are responsible for ensuring that their study complies with
applicable registry rules, ethics committee requirements, institutional policies, sponsor obligations and
national or regional law.
Definitions
Research Ethics Policy
What Studies Fall Under This Policy?
Authors should consider trial registration at the planning stage, not after manuscript preparation.
What Counts as a Clinical Trial?
For this policy, a clinical trial generally means research that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate effects on health outcomes.
Health-Related Interventions
Interventions may include medicines, biological products, surgery, devices, rehabilitation, behavioural treatments, education programs, dietary approaches, preventive care, process-of-care changes or similar health-related actions.
Health Outcomes
Health outcomes may include clinical outcomes, biomedical measurements, participant-reported outcomes, adverse events, pharmacokinetic measures, functional outcomes or other health-related endpoints.
Non-Trial Studies
Observational studies, surveys, case reports and secondary data analyses may not always require trial registration, but authors should disclose registration or protocol availability where relevant.
Acceptable Registries
Public, Searchable and Recognized Trial Registration Records
Authors should use a recognized public registry appropriate to the study location, regulatory environment and participant population. Registry records should be publicly accessible, searchable and sufficiently complete at the time of registration.
Clinical Trials Registry - India (CTRI)
Best for: Trials conducted in India or trials with participating Indian sites
Authors conducting clinical trials in India should normally register with CTRI before enrolling the first participant.
ClinicalTrials.gov
Best for: International and United States-based clinical trials
A widely used public registry and a data provider to the WHO International Clinical Trials Registry Platform.
WHO ICTRP Primary Registries
Best for: Trials registered in recognized national or regional primary registries
Acceptable where the registry is part of the WHO ICTRP Registry Network and provides a public searchable record.
Regional regulatory registries
Best for: Trials requiring registration under applicable regional law or regulatory authority
Examples may include recognized European, national or regional clinical trial systems where applicable to the trial location.
Author Requirements
What Authors Must Provide at Submission
Manuscripts reporting clinical trials should arrive with complete registration, ethics and reporting information. Missing details may delay editorial screening or make the manuscript unsuitable for review.
- Register the clinical trial prospectively in an acceptable public registry before participant enrolment whenever required by this policy, journal policy or applicable law.
- Provide the registry name, trial registration number, registration date and registry URL during submission.
- Include the trial registration number at the end of the abstract or in a clearly identified manuscript section where the journal template requires it.
- Submit ethics committee or institutional review board approval details, including approval reference number and approval date where available.
- State whether informed consent was obtained from participants or their legally authorized representatives.
- Ensure that primary and secondary outcomes reported in the manuscript are consistent with the registry record or explain any justified changes transparently.
- Provide a data sharing statement for clinical trial reports where applicable to the journal, discipline or registry requirement.
- Follow relevant reporting guidelines such as CONSORT for randomized trials and include a completed checklist or flow diagram where applicable.
- Update the registry record when trial status, recruitment, outcomes, protocol details or publication citation information changes.
- Disclose sponsor, funder, conflict of interest and author contribution information accurately.
Submission Documents
Clinical Trial Submission Readiness Table
Authors should prepare the following information before submitting a clinical trial manuscript.
| Required / Recommended Item | Purpose |
|---|---|
| Trial registration details | Registry name, trial ID, registration date and public registry link. |
| Ethics approval information | Committee name, approval number, approval date and jurisdiction/institution. |
| Participant consent statement | Informed consent wording, consent waiver explanation or legally valid approval basis. |
| Study protocol or protocol summary | Trial design, interventions, outcomes, sample size and analysis plan. |
| Reporting checklist | CONSORT or other relevant guideline checklist and trial flow diagram where applicable. |
| Funding and sponsor declaration | Funder role, sponsor involvement and independence of analysis/reporting. |
| Data sharing statement | Whether de-identified participant data, protocol or analysis plan will be available, and under what conditions. |
| Conflict of interest declaration | Financial, professional, institutional and personal interests related to the trial. |
Editorial Handling
How the Publisher Handles Registration Concerns
Editorial assessment considers whether registration, ethics approval, consent, outcomes and reporting are transparent, verifiable and consistent with responsible scholarly communication.
Important editorial position
Retrospective registration is not equal to prospective registration.
If registration occurred after participant enrolment, authors must disclose the timing and reason. Acceptance, review or publication is not guaranteed merely because a delayed registry entry exists.
| Situation | Editorial Action |
|---|---|
| Prospectively registered trial | Proceed to editorial screening if ethics approval, consent, reporting and manuscript documentation are complete. |
| Registered after participant enrolment | Require explanation for delayed registration; editors may request additional documentation and may publish a registration-timing statement if considered. |
| Unregistered interventional clinical trial | Normally not considered for publication unless the editor records a rare, justified exception consistent with ethical publishing standards. |
| Registry record missing essential details | Ask authors to correct/update the registry record and explain discrepancies before peer review or before acceptance. |
| Outcome discrepancies | Require transparent explanation of changed, added or omitted outcomes and may request protocol, statistical analysis plan or ethics records. |
| Secondary analysis of a registered trial | Require citation of the parent trial registration number and clear explanation of how the secondary analysis differs from prior reports. |
Reporting Standards
Registration Must Be Supported by Complete and Honest Reporting
Trial registration improves transparency, but it does not replace careful study reporting. Authors should follow the reporting guideline most suitable for the study design.
Randomized Controlled Trials
Authors should normally follow CONSORT reporting guidance, including trial design, randomization, allocation, participant flow, outcomes, harms and interpretation.
Non-Randomized Interventional Studies
Authors should use a relevant reporting guideline and clearly explain design, allocation process, intervention exposure, bias control and outcome assessment.
Pilot or Feasibility Trials
Authors should disclose feasibility objectives, recruitment, acceptability, intervention adherence and whether the trial is designed to support a future full-scale study.
Protocol Articles
Trial protocol submissions should include registry details, ethics approval, intervention description, outcomes, statistical plan and planned dissemination route.
Best Practice
Author and Editorial Responsibilities
Clinical trial publishing requires careful separation of scientific reporting, participant protection, registry transparency, sponsor influence and editorial independence.
Authors Should
- Register eligible interventional trials before participant enrolment.
- Keep trial registry records updated and consistent with the manuscript.
- Disclose ethics approval, consent, funding, sponsor role and conflicts of interest.
- Use recognized reporting guidelines and submit checklists where required.
- Explain protocol deviations, outcome changes or delayed registration transparently.
Authors Should Not
- Wait until manuscript submission to register a trial that should have been registered prospectively.
- Hide outcome switching, changed eligibility criteria or recruitment differences.
- Treat ethics approval as a substitute for public trial registration.
- Submit a trial report with unverifiable registration details.
- Make claims that are stronger than the registered outcomes or study design can support.
Editors May
- Ask for registry records, ethics approval letters, protocol documents or statistical analysis plans.
- Compare manuscript outcomes with registry outcomes during editorial screening.
- Seek methodological or ethics review where registration concerns are identified.
- Require published clarification for delayed registration in rare accepted cases.
- Reject submissions where registration, ethics or reporting integrity is inadequate.
Copy-Ready Templates
Funding & Contributor Templates
Clinical Trial Declaration Statements for Authors
Authors may adapt these statements according to the actual facts of the study. Do not copy any statement that is not accurate for the submitted manuscript.
Registered Clinical Trial Statement
This study was registered in [Registry Name] before enrolment of the first participant. Trial Registration Number: [Registration Number]. Registration Date: [Date]. Registry URL: [Public Registry Link].
Delayed Registration Explanation
This trial was registered after participant enrolment due to [brief reason]. The authors confirm that the registry record has been updated and that all outcome changes, protocol amendments and relevant deviations are disclosed in the manuscript.
Ethics Approval Statement
The study protocol was reviewed and approved by [Name of Ethics Committee/Institutional Review Board], Approval Number: [Number], Approval Date: [Date]. Written informed consent was obtained from all participants or their legally authorized representatives, unless waived by the approving authority.
Data Sharing Statement
De-identified participant data [will/will not] be shared. Data available: [describe]. Additional documents available: [protocol/statistical analysis plan/consent form]. Availability period: [dates]. Access criteria and contact: [details].
Secondary Analysis Statement
This manuscript reports a secondary analysis of a previously registered clinical trial. Parent Trial Registration Number: [Number]. This analysis differs from previous reports as follows: [brief explanation].
Official Resources
Authors Should Verify Current Registry and Reporting Requirements
Registry systems, reporting requirements and legal obligations can change. Authors should verify requirements directly from the relevant registry, institution, ethics committee, sponsor and regulatory authority.
FAQ
Clinical Trial Registration Policy FAQ
Common questions for authors preparing clinical trial manuscripts for submission.
Is clinical trial registration required for all health research?
No. This policy mainly applies to interventional clinical trials involving human participants. Observational studies, surveys, case reports and secondary analyses may have different registration requirements, but authors should disclose registry or protocol information where relevant.
When should a clinical trial be registered?
Eligible clinical trials should be registered before enrolling the first participant or at or before first participant consent, depending on the applicable standard, registry and legal context. Retrospective registration is not considered equivalent to prospective registration.
Which registry should Indian authors use?
For trials conducted in India or with Indian participating sites, authors should normally use Clinical Trials Registry - India (CTRI), while also meeting any international, sponsor or regulatory requirements applicable to the study.
Does ethics committee approval replace trial registration?
No. Ethics approval and trial registration serve different purposes. Human participant trials generally require ethics approval, and eligible interventional trials also require public registration.
Can an unregistered clinical trial be published?
Unregistered interventional clinical trials are normally not considered. Rare exceptions may be considered only with documented editorial justification, public registration, transparent explanation and clear publication statement.
Where should the trial registration number appear?
The registration number should appear in the abstract or a clearly identified trial registration section, and the submission form should include registry name, registration number, registration date and registry URL.
What if the registry outcomes differ from the manuscript outcomes?
Authors must explain any differences clearly, including protocol amendments, timing of changes, ethics approvals and whether outcome changes occurred before or after data analysis.
Are clinical trial protocols accepted?
Protocol submissions may be considered by relevant journals where within scope. Protocol manuscripts should include registry details, ethics approval, trial design, outcomes, analysis plan and dissemination plan.
Policy Pathway
Related Policies, Author Actions and Trust Pages
This policy is connected with UnivColl Publications' wider publishing ecosystem, including author guidance, editorial independence, publication ethics, metadata readiness and official support routes. Use the related links to move to the next practical step without relying on disconnected or informal information.
Publication Integrity
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Publication Malpractice Report
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Complaints and Appeals
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Contact Publisher
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Policies and Guidelines
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Publication Ethics
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Peer Review Policy
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Transparency and Responsible Publishing
Policy Use Does Not Create Publication or Indexing Guarantees
UnivColl Publications uses policy pages to support transparent communication, fair editorial handling, author awareness and scholarly record integrity. Submission, payment, policy compliance or support communication must not be treated as a promise of acceptance, indexing, citation, ranking or any third-party database outcome.
Publication Ethics
Editorial and publication decisions should remain evidence-based, policy-led and independent.
No Guaranteed Acceptance
Acceptance depends on scope, originality, review suitability, ethical compliance and editorial decision.
Metadata Ready
Published records may be supported with structured metadata, DOI references and correction workflows where applicable.
Documented Support
Queries should include manuscript ID, DOI, transaction reference or policy concern details where available.