CLINICAL TRIAL REGISTRATION

Clinical Trial Registration & Reporting

The Al-Najam Journal of Medical and Life Sciences (ANJMLS) considers reports of randomized controlled trials (RCTs) only when they comply with applicable International Committee of Medical Journal Editors (ICMJE) recommendations. Clinical trials should be prospectively registered in a recognized clinical trial registry before enrollment of the first participant. The registration number should be clearly stated at the end of the abstract and in the manuscript.

⚠️ Registration Requirement:
Retrospectively registered or unregistered clinical trials may not be considered for publication as RCT reports. Pilot or feasibility studies will not automatically be classified as RCTs or original research unless they meet the journal's methodological and reporting requirements and are appropriately described by the authors.

Definition of a Clinical Trial

For the purposes of this policy, ANJMLS follows the ICMJE definition of a clinical trial as a research project that prospectively assigns individuals or groups of individuals to an intervention, with or without a concurrent comparison or control group, to evaluate the cause-and-effect relationship between a health-related intervention and a health outcome.

Health-Related Interventions

These may include drugs, medical devices, surgical or procedural interventions, behavioural or educational programs, dietary interventions, quality-improvement interventions, and changes to processes of care.

Health Outcomes

Outcomes may include biomedical or health-related measurements obtained from participants, including treatment effects, safety outcomes, adverse events, and pharmacokinetic measures.

Accepted Clinical Trial Registries

ANJMLS accepts clinical trials registered in recognized registries that meet applicable ICMJE and WHO standards. Examples include:

  • ✓ Primary registries recognized through the WHO International Clinical Trials Registry Platform (ICTRP).
  • ✓ ClinicalTrials.gov and other registries recognized by the ICMJE.
  • ✓ Clinical trials registered with or meeting applicable requirements of the relevant national regulatory authorities, where applicable.
  • ✓ Other recognized clinical trial registries listed or accepted under current ICMJE recommendations.
Registration Information: Authors should provide the registry name, unique registration number, date of registration, and relevant registration details within the manuscript. Any discrepancies between the registered protocol and the submitted manuscript should be transparently explained.