Get the free Amendment - ClinicalTrials.gov

Amendment Protocol Number:Reference Number:11C0160MPrincipal Investigator: Raffia HassanNCITGIB301.451.8742370893hassanr mail.NIH.gov(NIH Employee Name, Institute/Branch, Telephone and email)A Pilot/

How to fill out amendment - clinicaltrialsgov

How to fill out amendment - clinicaltrialsgov

1. To fill out an amendment on clinicaltrialsgov, follow these steps: 1. Log in to your clinicaltrialsgov account. 2. Navigate to the study page for which you want to submit an amendment. 3. Click on the 'Amendments' tab. 4. Click on the 'Create New Amendment' button. 5. Fill out the required fields in the amendment form, such as the amendment title, summary, description, and any other relevant information. 6. Review the completed amendment form to ensure all the information is accurate. 7. Click on the 'Submit' button to submit the amendment for review and approval. 8. Wait for the clinicaltrialsgov team to review the amendment and provide any necessary feedback or approval.

Who needs amendment - clinicaltrialsgov?

1. Anyone who is conducting a clinical trial and needs to make changes or updates to the trial protocol, informed consent form, or other study-related documents may need to submit an amendment on clinicaltrialsgov. This includes researchers, sponsors, investigators, or other individuals involved in clinical research.

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What is amendment - clinicaltrialsgov?

An amendment on ClinicalTrials.gov refers to any changes made to a clinical trial's information after it has been initially submitted. This can include modifications to the trial protocol, eligibility criteria, or any other aspects of the study.

Who is required to file amendment - clinicaltrialsgov?

The sponsor of the clinical trial is required to file amendments on ClinicalTrials.gov. This includes organizations or individuals responsible for the initiation, management, and/or financing of the clinical trial.

How to fill out amendment - clinicaltrialsgov?

To fill out an amendment on ClinicalTrials.gov, the sponsor must log into the ClinicalTrials.gov Protocol Registration and Results System (PRS), access their trial record, and submit the relevant changes through the designated amendment forms. They must ensure that all updated information complies with regulatory requirements.

What is the purpose of amendment - clinicaltrialsgov?

The purpose of filing an amendment on ClinicalTrials.gov is to ensure that the public has access to the most accurate and up-to-date information about the clinical trial as it progresses. This reflects any significant changes made to the trial design, conduct, or analysis.

What information must be reported on amendment - clinicaltrialsgov?

When filing an amendment on ClinicalTrials.gov, sponsors must report any updates to the study design, eligibility criteria, interventions, outcomes, or any other relevant information that has changed since the last submission.