Create Record and Enter Your Data

As a PRS user, you are responsible for:

ü  Entering your study data

ü  Ensuring that the data are correct

ü  Updating your records in a timely manner, as needed.

Once you enter your data, the AU PRS administrator will:

ü  Review the data for errors

ü  Release your records for posting on ClinicalTrials.gov

Steps for Creating a Record & Entering Data

1.       To enter your protocol into the system, click on “CREATE” on your PRS Main Menu screen. 

2.       You are now on the Data Entry Screen.  A Web-based data entry system where you can enter information on y our trial.

 You will be asked to enter some key registry data elements such as:

1.      Protocol Information

–Title/Protocol ID

–Brief Summary

–Study Type and Design

–# Participants

–Condition

–Intervention

–Study Arms/Description

–Outcome Measures

2.      Dates

–Start Date

–Completion Date

3.      Recruitment Information

–Recruitment Status

–Eligibility Criteria

–Facility Locations

4.      Administrative

–Sponsor

–Investigators

–Human Subjects Review (IRB Approval)

–Expanded Access

Data elements such as # participants, completion date, recruitment status, facility location(s), and expanded access will possibly change during the trial.

Once you have completed entering your data, you will need to review the information for edits on the Edit Protocol screen.