Instructions of ClinicalTrials.gov Protocol Registration

Transcription

1 Instructions of ClinicalTrials.gov Protocol Registration STEP I: Getting Started 1. Create an account: contact RU ClinicalTrials.gov Protocol Registration System (PRS) Administrator Rebecca Chen ( or to create an account. Please include CT.gov account request in the subject line, and provide the following four items: 1) CT.gov user name for Individual account Login-required for you to access your CT.gov account; be specific and pick a name that you ll remember. for Group account Login-required for you to access your CT.gov account; be specific to your research team, collaborative group, or department/unit (e.g. SchoolNameResearchTeam etc.) 2) Full name Your full name The full name of your group/department/unit 3) Telephone number 4) address Your phone number that can be used for CT.gov-related work An you will use for CT.govrelated work The phone number(s) of PI s and/or your group s CT.gov Point Person address(es) where messages can be sent and responded, preferably PI and/or CT.gov Point Person 2. Obtain login information: the PRS will send the account user(s) login information and initial password to the above (s). You ll be able to change your password once you have logged in. 3. Login at: Version Date 7/23/2014 page 1

2 4. Familiarize with Standard Function menu. The Standard Function menu is the main console for working in ClinicalTrials.gov. From here you can create/edit protocol records, view QA review comments, and change your password and/or associated with your user name. The Help section in the Standard Function menu provides helpful tools that can be used during protocol registration or results reporting. Version Date 7/23/2014 page 2

3 STEP II: Registering a Study With pertinent source information at hand, such as the protocol, informed consent document, and IRB application, entry of each registration is expected to take approximately 1-2 hours. 1. On the Standard Functions menu, under Protocol/Results Records, hit New Record and complete the study description template. 2. Note that the ClinicalTrials.gov-required fields are marked with a red asterisk (*) and the FDA-required fields are marked with a green. Taken together, these data elements represent the requirements for an adequate registration. If you do not complete these fields, your trial may not be considered "fully registered." Note also that each field of the template is labeled and linked to a definition. 3. Several fields are potentially confusing and should be completed as follows: Organization s Unique Protocol ID: Make sure the RU assigned IRB Protocol Number is provided. Secondary ID: Provide NIH Grant/Contract Award Number, other grant/funding number, unique identifiers from other registries etc, if applicable. Version Date 7/23/2014 page 3

4 Board Name/Board Affiliation/Board Contact: Board should reflect the IRB panel that reviewed the protocol. According to your school/campus, please indicate: Your school/ca mpus Health Science - Newark Health Science - New Brunswick Arts and Science/Le gacy Rutgers Board Name Rutgers Health Sciences IRB Newark campus Rutgers Health Sciences IRB New Brunswick/ Piscataway campus Rutgers Arts & Sciences IRB Board Affiliation Rutgers Business Phone Board Contact Business [email protected] rs.edu [email protected] s.edu Business Address 65 Bergen Street, SSB 511, Newark, NJ George Street Liberty Plaza, 3 rd Floor, Suite 3100, New Brunswick, NJ Rutgers Plaza, ASB III - 2nd Floor, New Brunswick, NJ For example: Responsible Party: For most studies, the Sponsor option should be selected and no other information will be required. The other two options, Principal Investigator and Sponsor-Investigator requires additional information be provided. It is important to know that, when Principal Investigator or Sponsor-Investigator is selected as Responsible Party, it is the investigator who must release the record for review and processing by ClinicalTrials.gov. Definition of Responsible Party can be found at Rutgers ClinicalTrials.gov website Requirement page ( Version Date 7/23/2014 page 4

5 Sponsor: The database will default to Rutgers, The State University of New Jersey. Although Rutgers is not actually the financial sponsor, choose Rutgers, The State University of New Jersey. Record Verification Date: Enter the month and year on which you complete and submit the record. Note: This field generates the automatic reminders, do not leave it blank. Conditions: Use NLM s Medical Subject Heading (MeSH) controlled vocabulary terms. If you do not, the ClinicalTrials.gov staff is likely to delete your term and choose one of their own. Keywords: Use NLM s Medical Subject Heading (MeSH) controlled vocabulary terms. If you do not, ClinicalTrials.gov staff is likely to delete your term and choose one of their own. Version Date 7/23/2014 page 5

6 4. Address common errors: Verify there are no warning messages or errors when completing the application. These are common errors which will prevent the approval/release of your registration. Version Date 7/23/2014 page 6

7 5. Complete your application: Click Complete when the application is completed in full and is ready to be submitted for review/approval/release. This will notify the Institutional RU PRS Administrator that a record is pending his/her review/approval/release to the Central ClinicalTrials.gov. STEP III: Mandatory Update After initial registration of a clinical trial, it will be necessary to make updates to the record to reflect changes during the conduct of the trial. It is particularly important to keep the Primary Completion Date (anticipated or actual) current because it will impact when the basic results information need to be entered for applicable clinical trials under FDAAA. For Active Studies ICMJE policy requires you to update/verify your registration at least every 6 months. FDAAA requires updates/verification annually, or within 30 days of status change. 1. Log into ClinicalTrials.gov and go to Edit Record 2. If changes have been made to the protocol that effect information listed in the ClinicalTrials.gov registration, make appropriate changes. 3. If no changes have occurred in the last 6 months, update the Record Verification Date by clicking the Edit button next to the field. 4. Enter current month and year. 5. Click Complete when completed in full for submission to the PRS Administrator for approval/release. For Closed Studies 6. If the trial is complete (whether concluded or terminated prior to conclusion), registration must be updated within 30 days. Version Date 7/23/2014 page 7

8 ADDITIONAL INFORMATION: 1. I forgot my password, Help! Contact RU PRS Administrator Rebecca Chen at [email protected] or She will help you. 2. How do I change the address associated with my username? Login at: On the Standard Functions menu, under User Account, hit Update User Information Enter new . Note, messages from ClinicalTrials.gov will be sent to this address. 3. PRS User s Guide This document, created by National Library of Medicine provides step-by-step instructions for entering, modifying, and releasing protocol records using the ClinicalTrials.gov Protocol Registration System. Go to: and log into your ClinicalTrials.gov account Select User s Guide in Help Section of the Standard Function list. CONTACT the Institutional ClinicalTrials.gov PRS Administrator: Human Subjects Protection Program Rebecca Chen [email protected] Version Date 7/23/2014 page 8