Important threshold
An RCT is not a “small student project.” It is an interventional human study with substantial ethical, regulatory, safety, operational and statistical requirements. The institution, sponsor and applicable health authority determine which approvals and trial infrastructure are required.
Approval and governance
Usually needs formal review / authorisation
- Formal ethics/research review before recruitment.
- Applicable regulatory/health-authority approval for the intervention and jurisdiction.
- Prospective public trial registration before the first participant is recruited/consented, consistent with WHO/ICMJE expectations.
- Informed consent unless an authorised ethics body approves a legally valid alternative.
- Sponsor responsibilities, safety monitoring, protocol-deviation handling, data management and GCP-compliant conduct as applicable.
May follow a lighter or different route
- Some low-risk behavioural or educational interventions may have lighter regulatory requirements than drug/device trials, but they remain interventional research and still require institutional/ethics determination.
Do not do this
- Do not randomise, consent or deliver the study intervention before approval and registration requirements are satisfied.
- Do not conceal protocol changes or switch primary outcomes after seeing data.
- Do not use predictable allocation methods such as alternating patients when true randomisation is required.
Mediclinic Middle East publicly states that research projects carried out at MCME are to receive approval from its internal Research and Ethics Committee and applicable local regulatory authorities before initiation. The exact route varies by project, facility and emirate. Dubai projects may involve DSREC depending on applicability. This hub must therefore route users to the Research Office and current local forms rather than declaring a project “ethics exempt.” Institution-specific forms and contacts will be inserted after verification.
Step-by-step workflow
Confirm that randomisation is ethically and scientifically justified
There must be genuine uncertainty about which intervention is preferable for the study question, and the trial must be capable of changing knowledge. If the sample size or implementation cannot answer the question, exposing participants to trial burden is difficult to justify.
Define sponsor, PI and operational responsibilities
Identify who is legally/operationally responsible for sponsorship, protocol ownership, monitoring, safety reporting, investigational product/device accountability if relevant, insurance/indemnity, data management and final reporting.
Specify the trial design
Choose parallel, crossover, cluster, factorial or another design; superiority, non-inferiority or equivalence framework; allocation ratio; number of arms; and unit of randomisation.
Define participants and setting
Write inclusion/exclusion criteria that are clinically justified and measurable before randomisation. Define recruitment sites, screening route and recruitment targets.
Define intervention and comparator in reproducible detail
Specify exactly what each group receives, dose/intensity, timing, duration, permitted co-interventions, adherence measurement and discontinuation rules.
Choose primary and secondary outcomes
Define one primary outcome whenever feasible, its measurement instrument, time point and analysis metric. Secondary outcomes should be prespecified. Define harms/safety outcomes separately.
Calculate sample size
Specify target effect, variance/event rate, alpha, power, allocation ratio, anticipated attrition and design effects such as clustering. Non-inferiority trials require a justified margin.
Create the randomisation and allocation-concealment plan
Use a reproducible random sequence and prevent recruiters from predicting the next assignment. State stratification/blocking if used and separate sequence generation from enrolment when possible.
Plan blinding
State who can be blinded: participants, treating clinicians, outcome assessors, data analysts. If blinding is impossible, reduce performance/detection bias through objective outcomes, blinded adjudication or standardised procedures.
Write a SPIRIT 2025-compliant protocol and statistical analysis plan
Complete protocol items covering rationale, design, interventions, outcomes, assignment, data, monitoring, ethics, dissemination and administrative information. Finalise the primary statistical approach before unblinded outcome analysis.
Obtain ethics, institutional and regulatory approvals
Submit the final protocol, investigator materials, consent form, recruitment materials, data/security plan, safety plan and other required documents. Resolve all conditions before activation.
Register prospectively
Register the trial in an accepted public registry before the first participant is recruited/consented, as required by applicable policy. The registry should match the approved protocol, particularly primary outcomes and time points.
Train the study team and test the workflow
Train on eligibility, consent, randomisation, intervention delivery, adverse events, source documentation, data entry, deviations and emergency unblinding. Run a dry test before first enrolment.
Screen, consent and randomise
Maintain a screening log. Obtain valid consent before trial procedures unless specifically authorised otherwise. Confirm eligibility immediately before randomisation and record allocation exactly once.
Conduct follow-up and safety monitoring
Follow protocol windows, document adherence, adverse events, serious adverse events and deviations, and report safety issues through required channels. Apply stopping rules/DSMB procedures if specified.
Lock data and analyse by the prespecified estimand
Resolve data queries before lock. Primary analysis commonly follows the randomised groups (intention-to-treat principle), but the exact estimand, missing-data strategy and additional per-protocol/sensitivity analyses should be prespecified.
Report with CONSORT 2025
Include participant flow, registration, protocol access, allocation, blinding, intervention/comparator as delivered, outcomes, harms, effect estimates with precision, deviations, limitations, funding and data-sharing information.
Close and disseminate
Complete regulatory/institutional close-out, update the registry with completion/results as applicable, archive essential documents, publish results regardless of direction and add the verified publication to Research Pulse.
Final checklist
- Sponsor/PI responsibilities assigned.
- SPIRIT 2025 protocol complete.
- Primary outcome/time point fixed.
- Sample size justified.
- Randomisation and concealment valid.
- Ethics/regulatory approvals complete.
- Trial prospectively registered.
- Consent and safety procedures trained.
- Statistical analysis plan final before unblinding.
- CONSORT 2025 checklist and flow diagram completed.