Get the free ClinicalTrials.gov Study Record Review - OHSU

ClinicalTrials.gov Study Record Review InvestigatorInitiated Trial (IIT) Registration and Results Reporting Quality Control Checklist for Principal Investigators and Study ManagersAdapted with permission

How to fill out clinicaltrialsgov study record review

How to fill out clinicaltrialsgov study record review

1. Login to clinicaltrialsgov using your credentials.
2. Go to the 'Study Record' tab.
3. Click on 'Add New Study Record' button.
4. Fill in the required information such as study title, study type, study phase, etc. in the provided fields.
5. Provide a brief description of the study objectives and methods.
6. Enter the recruitment status, study start and end dates, and anticipated completion date.
7. Include the eligibility criteria for participants.
8. Specify the primary and secondary outcome measures.
9. Fill in the intervention details, including the intervention name, description, and arm details.
10. Attach any relevant documents such as protocols, informed consent forms, etc.
11. Review the completed study record for accuracy.
12. Click on 'Submit' to finalize the study record review.

Who needs clinicaltrialsgov study record review?

1. Researchers who are conducting clinical trials and want to register their study on clinicaltrialsgov need the study record review.
2. Regulatory authorities, sponsors, and ethics committees also require the study record review as part of the oversight process.
3. Potential participants and the general public can access the study record on clinicaltrialsgov to make informed decisions about participating in a clinical trial.

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What is clinicaltrialsgov study record review?

ClinicalTrials.gov study record review is the process of examining the data and information submitted to the ClinicalTrials.gov database, which is a registry of clinical trials conducted around the world. This review ensures that the information is complete, accurate, and in compliance with regulatory requirements.

Who is required to file clinicaltrialsgov study record review?

Any sponsor or investigator conducting a clinical trial that meets the applicable criteria, including those receiving federal funding or support, is required to file a study record review on ClinicalTrials.gov.

How to fill out clinicaltrialsgov study record review?

To fill out a ClinicalTrials.gov study record review, sponsors or investigators need to create an account on the ClinicalTrials.gov website, provide detailed information about the study, including its design, methodology, outcomes, and results, and ensure that all required fields are completed before submission.

What is the purpose of clinicaltrialsgov study record review?

The purpose of the ClinicalTrials.gov study record review is to promote transparency in clinical research, facilitate access to study information for patients and healthcare providers, and ensure compliance with federal laws and regulations concerning clinical trials.

What information must be reported on clinicaltrialsgov study record review?

Information that must be reported includes the study's title, purpose, design, participant eligibility criteria, locations, outcomes, and results, among other relevant details relating to the clinical trial.