Planning a randomised controlled trial, a non-randomised trial or a quasi-experimental study for your FCPS, MS/MD thesis or a journal paper? Most good journals will not publish an interventional study unless it was registered in a recognised registry before the first patient was enrolled. ClinicalTrials.gov is the registry most Pakistani researchers use. It is free, it is accepted by journals worldwide, and it gives your study an NCT number that you quote in your paper.
The hard part is not the form. It is getting a PRS (Protocol Registration and Results System) account, and then getting your record through the PRS review without repeated comments. This post explains the whole process and shows which Pakistani hospitals and universities already have a PRS account.
ClinicalTrials.gov is not the only accepted registry. Journals also accept any WHO primary registry. See the full list in WHO Primary Clinical Trial Registries: Where Can Pakistani Researchers Register a Trial?
Want UPMED to do it for you? We help you create your own PRS account, enter your study and follow up until your NCT number is issued. WhatsApp 0304 2397393 or email [email protected].
Which studies need to be registered?
Journals that follow ICMJE recommendations treat as a clinical trial any study that prospectively assigns people, or groups of people, to an intervention, with or without a comparison or control group, to study its effect on a health outcome. So registration is not only for RCTs:
| Study type | Register? |
|---|---|
| Randomised controlled trial (RCT) | Yes, before the first patient is enrolled |
| Non-randomised controlled trial (e.g. alternate allocation, allocation by ward or hospital) | Yes |
| Quasi-experimental study (before-after, with or without a control group) | Yes |
| Single-arm trial (one group gets the intervention) | Yes |
| Observational study (cross-sectional, case-control, cohort) | Not required by ICMJE, but it can be registered on ClinicalTrials.gov as an observational study. Some journals and supervisors like to see it. |
Interventions include drugs, surgical procedures, devices, physiotherapy, behavioural and educational interventions, and changes in care processes. If in doubt, register before you start: an unregistered interventional study is hard to publish.
Step 1: Check if your institution already has a PRS account
Search your hospital, medical college or university in the table below. The names are exactly as they appear on the official ClinicalTrials.gov list of organizations with PRS accounts.
Showing 1–5 of 343 rows
| Organization (exact name on the PRS list) | City | Province | Listed under |
|---|---|---|---|
| 28 Military Dental Centre Lahore | Lahore | Punjab | Government |
| Abasyn University Peshawar | Peshawar | Khyber Pakhtunkhwa | University/Organization |
| Abbas Institute of Medical Sciences | Muzaffarabad | Azad Kashmir | University/Organization |
| Abbasi Shaheed Hospital | Karachi | Sindh | University/Organization |
| Abdul Wali Khan University Mardan | Mardan | Khyber Pakhtunkhwa | University/Organization |
Record taken from: https://register.clinicaltrials.gov/prs/html/account-organizations.html
- Your institution is listed: it has a PRS administrator who can create a user login for you. Ask your research or ethics office who the administrator is.
- Your institution is not listed, or nobody knows who the administrator is: you can apply for an individual account. This is the route most postgraduate trainees take.
Step 2: Create an individual PRS account
If your institution is not on the list, apply for your own account. You will be the sponsor-investigator and the PRS administrator of your account. The account is free and is usually created within about 2 business days. Apply here: Apply for a PRS Account (ClinicalTrials.gov).
Read the full guide: How to Create a ClinicalTrials.gov PRS Account from Pakistan: Every Field Explained. It covers every field of the form, what to write for DRAP as the regulatory authority, and how to fix each form error.
No time for forms? UPMED can help you apply for your account and register your study. WhatsApp 0304 2397393 or email [email protected].
Step 3: Keep these documents ready
- Approved synopsis or protocol (final version)
- Ethics committee (IRB/ERC) approval letter with the approval number and date
- Expected start date and completion date
- Sample size and how it was calculated
- Primary and secondary outcomes, each with a clear time frame
- Inclusion and exclusion criteria
- Intervention and comparison groups, with dose, route and duration where relevant
- Name, email and phone number of the principal investigator and the study site address
Step 4: Enter the study record
Once the account is active, the study is entered module by module: study identification, status and dates, sponsor and collaborators, oversight (ethics approval), description, conditions, design, arms and interventions, outcome measures, eligibility, contacts and locations, and the plan for sharing individual participant data. The record is then released to ClinicalTrials.gov for review.
Step 5: PRS review and the NCT number
PRS staff review every record before it is published. If something is unclear they send review comments, and the record has to be corrected and released again. The NCT number is issued only after the record passes review. The most common reasons for comments are:
- Outcome measures with no time frame, or with a scale named but no detail of how it is scored
- Arms and interventions that do not match each other
- Dates, enrollment and study status that contradict each other
- Vague eligibility criteria
- A brief title or summary that does not describe the study clearly
Every round of comments costs time. If your first patient date is close, a clean first submission matters.
Let UPMED register your study
UPMED guides and supports you through the complete process, from your PRS account application to the NCT number:
- Help in applying for your own PRS account (the account is in your name and belongs to you, not UPMED)
- Complete entry of your study record from your synopsis or protocol
- Outcome measures, arms and eligibility written in the format PRS reviewers expect
- Replies to all PRS review comments until the record is accepted
- Follow-up until your NCT number is issued
- RCTs, non-randomised trials, quasi-experimental studies and observational studies
For packages and fees, contact us:
- WhatsApp: 0304 2397393 (save the number as “UPMED”)
- Email: [email protected]
Please send your approved synopsis and ethics approval letter with your message so we can guide you quickly.
Frequently asked questions
Does ClinicalTrials.gov charge a fee?
No. Registration on ClinicalTrials.gov is free. UPMED’s fee is for the work of preparing, entering and following up your record.
When should I register?
After ethics approval and before the first patient is enrolled. A trial registered after enrollment starts is marked as retrospectively registered, and many journals will not accept it.
Whose name will the account be in?
Yours. The account and the record belong to you. You keep the login after the NCT number is issued.
Do I need to update the record later?
Yes. The status (recruiting, completed) and dates should be kept current, and the record should be reviewed at least once a year. UPMED can do these updates for you.
Doing a systematic review instead? See How to Register Your Systematic Review on PROSPERO.
New to trial design? Read Randomised Controlled Trials: Randomisation, Allocation Concealment, Blinding and Trial Registration.
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