Before you can register a trial on ClinicalTrials.gov you need a PRS (Protocol Registration and Results System) account. First check whether your hospital or university already has one in our list of Pakistani organizations with a PRS account. If it does, ask its PRS administrator for a user login. If it does not, apply yourself using this guide. The account is free. (Not sure ClinicalTrials.gov is the right registry for you? See WHO Primary Clinical Trial Registries.)
The same account is used for every kind of study: randomised controlled trials, non-randomised trials, quasi-experimental (before-after) studies, single-arm trials and observational studies. You need only one account for all of them.
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].
Where to apply
- Application form: Apply for a PRS Account (ClinicalTrials.gov)
- Official instructions: How to Apply for a PRS Account
- Login page (after your account is created): register.clinicaltrials.gov
Open the application form in a new tab and keep this guide open beside it. The form has five parts. Fill them in this order.
Part 1: Terms and conditions
Read the terms and select Accept. By accepting you agree that:
- Your study has ethics approval and follows the rules of the national health authority
- Any change in recruitment status will be updated within 30 days
- All other data will be reviewed and updated at least once every 12 months
- All study data will be in English
- Old versions of your record stay visible to the public
Part 2: Sponsor information
The sponsor is the person or organization responsible for starting and running the study. If you are doing your own study for FCPS, MS/MD or a paper, you are the sponsor-investigator.
| Field | What to enter |
|---|---|
| Type of Organization * | Select the type that describes you. Doctors applying on their own from a hospital or medical college usually select University/Organization. |
| Country * | Pakistan |
| Organization Name * | Two options: 1. Your own full name, for example Dr Ayesha Khan. The account belongs to you and stays with you if you change jobs. 2. Your current hospital or college, for example Mayo Hospital, Lahore. Use this only if it is not already in our list of organizations with a PRS account. If it is listed, ClinicalTrials.gov will ask you to use the existing account through its administrator. Other doctors from your institution will later have to use this account too. |
| Organization Address * | Complete postal address with city and postal code, for example Department of Medicine, Mayo Hospital, Lahore 54000, Pakistan. Plain text only, no website link. |
| Organization Abbreviations and Acronyms | Leave blank. |
| Parent Organizations, if any | Leave blank, or write your hospital or college. |
| Name of Individual * | Your full name, exactly as on your synopsis and ethics approval letter. |
| Phone * | With country code: +92 3XX XXXXXXX. Do not start with 0. |
| Email * | An email you will keep for years. All PRS messages, login details and review comments come here. |
| Organization Web Site (optional) | Leave blank. |
| Funding Organization | Self-funded, or the name of the body funding the study. |
Part 3: PRS administrator information
The PRS administrator manages the account and is the contact person for ClinicalTrials.gov staff. For an individual researcher, this is you again.
| Field | What to enter |
|---|---|
| Administrator Name * | Your full name |
| Affiliation (if not the sponsor) | Your hospital, medical college or university |
| Administrator Phone * | +92 3XX XXXXXXX |
| Administrator Email * | The same email as above |
Part 4: Regulatory information
The regulatory authority can be a national health authority or an ethics committee. Enter Pakistan’s national drug regulator:
| Field | What to enter |
|---|---|
| Regulatory Authority * | Drug Regulatory Authority of Pakistan (DRAP) |
| Regulatory Authority Address * | Prime Minister’s National Health Complex, Park Road, Chak Shahzad, Islamabad, Pakistan |
Part 5: Attestation and submit
Tick “To the best of my knowledge, the above information is true and correct” and submit the form.
Form errors and how to fix them
If a required field is empty or in the wrong format, the form shows errors at the top. Fix each one and submit again.
| Error | Fix |
|---|---|
| Terms and conditions must be accepted | Select Accept at the top of the form. |
| Sponsor Organization Type is missing | Choose an option in Type of Organization. |
| Sponsor Country is missing | Select Pakistan. |
| Sponsor Organization Name is missing | Fill in Organization Name. |
| Sponsor Organization Address is missing or may contain a hyperlink | Type the full postal address. Remove any web address or link. |
| Sponsor Official Representative Name is missing | Fill in Name of Individual. |
| Sponsor Official Representative Phone is missing or has invalid format | Write the number with the country code, e.g. +92 300 1234567. |
| Sponsor Official Representative Email is missing or has invalid format | Check the email for spaces or typing mistakes. |
| Administrator Name is missing | Fill in Administrator Name (your name). |
| Administrator Phone is missing or has invalid format | Same format as above, with +92. |
| Administrator Email is missing or has invalid format | Enter a valid email address. |
| Regulatory Authority Name is missing | Enter Drug Regulatory Authority of Pakistan (DRAP). |
| Regulatory Authority Address is missing or may contain a hyperlink | Enter the DRAP address as plain text, without a link. |
Form still not going through? Send UPMED a screenshot of the errors on WhatsApp 0304 2397393 or email [email protected], and we will sort it out for you.
After you submit
- Wait for the email. The account is usually created within about 2 business days. ClinicalTrials.gov may email you first if something needs clarifying, so reply quickly.
- Note your three login details. The email gives an Organization name (your account’s login code), a Username and a temporary password. Check your spam folder too.
- Log in. Go to register.clinicaltrials.gov and enter all three.
- Change the password straight away from the Accounts menu, and save the new login details safely. You will need them for every update until your study is complete.
Tips
- Apply only once. One account holds all your future studies.
- Use the same spelling of your name everywhere: account, synopsis, ethics letter and study record.
- For account problems, write to [email protected].
Want UPMED to do it for you?
UPMED helps you create your own account, enters your complete study record, answers all PRS review comments and follows up until your NCT number is issued. Read more in How to Register Your Clinical Trial on ClinicalTrials.gov from Pakistan. For packages and fees, contact us on WhatsApp at 0304 2397393 or email [email protected].
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