Transcript Overview of Clinicaltrials.gov (Benefits & Burdens?)

ClinicalTrials.gov
How to Register Your Trial
Adapted from the work of the Clinical and Translational Science
Awards (CTSA) program’s Clinical Trials Registration Workgroup
of the Regulatory Knowledge Key Function Committee
2013
http://catalyst.harvard.edu
ClinicalTrials.gov
• Database operated by the National Library of Medicine
(NLM)
• What you’ll find at ClinicalTrials.gov:
– Registration
– Results (including Adverse Events)
• *This presentation focuses solely on registration.*
2
ClinicalTrials.gov – Registration Information
• Description of study
– Study type, phase, design, outcome measures
• Recruitment information
– Eligibility criteria, locations, recruitment status
• Administrative and other information
– Key dates and contact information
• Helpful links to add
– MEDLINE publications, consumer health information,
FDA information
3
ClinicalTrials.gov – Account Information
• Each institution has a umbrella ClinicalTrials.gov account.
• Each institution has a “PRS Administrator” assigned.
• The PRS Administrator can create individual accounts for
investigators and study staff at the institution within the
institutional account.
• The Responsible Party (RP) is responsible for registering
the study.
• Each study receives only one record, regardless of
number of sites.
4
ClinicalTrials.gov – Obtaining your log-in and
user account
• Provide the following information to your PRS
Administrator:
• Desired user name
• Full name (e.g., John J Smith, MD)
• Email address
• Phone number
• PRS Administrator sends request to ClinicalTrials.gov
• ClinicalTrials.gov emails user notifying of account
creation and provides temporary password (within
two days)
• You may now log into the ClinicalTrials.gov Protocol
Registration System: https://register.clinicaltrials.gov/
5
ClinicalTrials.gov Login Page
Log in:
https://register.clinicaltrials.gov/
Organization Name = Your Institution
6
Responsible Party vs. Record Owner
The Responsible Party (RP) is responsible for registering their study
record on ClinicalTrials.gov, ensuring accuracy, and making sure that the content is up
to date. The RP is the only one that can “approve” and “release” the record to
ClinicalTrials.gov.
Record Owner (RO) can be anyone with an account; the record is stored in
RO’s account.
TIPS:
•
•
If the RP is the Principle Investigator (PI), it may be easiest if the PI is also the RO.
The RO can use the “access list” to grant additional users access to the specific
record for editing purposes (e.g. if the PI is the RO, he/she can provide access to
the study coordinator by selecting the study coordinator from the access list.)
7
Responsible Party Refresher
ICMJE: Anyone can register, but generally it’s the PI.
FDAAA: The Responsible Party (RP) defined as IND / IDE holder
OR
If no IND/IDE:
• The RP is the industry, cooperative group, consortium or other
external sponsor that initiated the study
OR
• If initiated by a principal investigator, the RP is the grantee
institution (e.g. your institution) OR, if no external funding, the PI
8
8
Responsible Party Refresher (cont’d)
• Under FDAAA, RP can be designated to another
party that:
–
–
–
–
Is responsible for conducting the study
Has access to and control over the data
Has the right to publish the trial results, AND
Has the ability to meet the requirements
• Example of RP designation
– PI initiated study at institution X funded by NHLBI
• Institution X is the RP
• Institution can designate the PI as the RP
9
9
ClinicalTrials.gov Menu
After log in:
Blue Menu box is what
everyone sees.
(PRS Administrators see both blue and yellow
menu boxes)
Check out the “Help” section
To create a new protocol record,
click “Create”
Get prepared for
registration!
Read these
documents before
you try to register
your study:
•
Quick Start Guide
•
FAQs
•
User’s Guide
Protocol Data
Element Definitions
•
10
Registration in Create/Modify View
* = Required fields
Click on any underlined words in the left
column for the official definition and number
of characters allowed for this field.
FDAAA = this information is required to comply with
US Public Law 110-85, Section 801 – FDAAA
(FDAAA) = this information may be required
to comply with FDAAA.
11
Review Board Approval
Pfizer Enter IRB
information here
Pfizer
Pfizer
Pfizer
Pfizer
Pfizer
See the list of oversight authorities
for a comprehensive list of all such
organizations world-wide. E.g. IRB,
FDA etc.
12
Responsible Party Designation
Each institution may handle names and titles
of the responsible party differently. Make sure
you understand your institution’s policies.
Note: the investigator must be registered with ClinicalTrials.gov
to appear on the list.
The list is organized by the first letter of the username, for
example, Thomas Adams (tadams) would appear with the “T”s.
13
Registration Tips:
•
Brief title and summary should
be in lay language.
•
Caution: abbreviations must be
identified the first time they
are used in the protocol
section, for example in the
brief summary or detailed
description.
•
Overall Recruiting Status and
Recruiting Status in the
locations must match
•
Dates are needed for Study
Start Date, and Primary and
Study Completion Dates
•
Change the Verification Date
to the current month and year
(this updates the record)
Keep the primary
completion date current.
This is an important date
for ClinicalTrials.gov –
your study may end up
on the “problem list” if
the date is not current.
14
Entering the Study Type
15
Entering the Study Type: DEFINITIONS
Observational: Studies in human beings in which biomedical and/or health outcomes are
assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic,
therapeutic, or other interventions, but the investigator does not assign specific interventions to the
subjects of the study.
Interventional: Studies in human beings in which individuals are assigned based on a
protocol to receive specific interventions. Subjects may receive diagnostic, therapeutic,
or other types of interventions. The assignment of the intervention may or may not be random. The
individuals are then followed and biomedical and/or health outcomes are assessed.
Expanded Access:
Records describing the procedure for obtaining an experimental drug or
device for patients who are not adequately treated by existing therapy, who do not meet
the eligibility criteria for enrollment, or who are otherwise unable to participate in a
controlled clinical study. Expanded access records are used to register all types of non-protocol
access to experimental treatments, including protocol exception, single-patient IND, treatment IND,
compassionate use, emergency use, continued access, and parallel track.
Definitions from: https://register.clinicaltrials.gov/prs/html/definitions.html
16
How to Enter Outcome Measures easur
Outcome measure information:
Please be as specific as possible.
•
Title: include the name of the specific
measure. Avoid using verbs, that is, do not put
“To determine…”
•
Time Frame: must have a time point at which
the outcome is assessed for the specific metric
used (hours, days, weeks, years) Hint: specify
which study day it is measured - do not use
“until the end of study or death.”
For guidance see page 3 of:
http://prsinfo.clinicaltrials.gov/ProtocolD
etailedReviewItems.pdf.
•
Description: describes what will be measured,
not why it is measured. If the outcome measure
is a questionnaire or scale, provide the range
and what low or high scores mean.
•
Safety Issue: Is this outcome measure
assessing a safety issue?
17
Example of Problematic Primary Outcome
Measure
This outcome measure is a problem
because the title and time frame are
not specific enough.
How will the study measure nausea?
When will it be measured, specifically?
If these fields are not clear, the study
registration will get comments from
the QA reviewers, and could be
delayed.
18
Example of Corrected Primary Outcome
Measure*
This outcome measure is now much more specific and
provides a specific time when it will be measured.
Notice that additional information is provided about the
nausea scale: the range, what the beginning and end of the
scale mean, and the definition of “improved.”
* Note: Secondary Outcome Measure fields require same information
19
How to Enter Arms/Interventions Information
If the same intervention
(e.g., drug) is used in
multiple arms, enter
information about the
intervention only once,
even if the dosage is
different.
Use the Cross-Reference
section to specify which
arm the intervention is
associated with.
20
Central Contact/Location Info
Central Contact:
• Please list the person
providing centralized
coordinated recruitment
information.
Locations:
• Please list all sites if the
study is multi center.
• Recruitment Status should
match the Overall
Recruiting Status above.
Note: Please fill this section in
completely. This information
will give participants the
correct information on whom
to contact.
21
Completed all fields and Ready to Release your
study on ClinicalTrials.gov
Please ensure you have thoroughly
reviewed your study record…
• All fields should be completely filled
out and in lay language (where
possible)
• All red errors must be corrected
• Any misspelled words should be
corrected
• Acronyms and abbreviations should be
spelled out
Be sure your study record complies with the ClinicalTrials.gov standards.
See http://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf.
22
Next Action:
Complete: The person updating
the record will click on
“Complete” to indicate that
the study is ready for the
“Approve” and “Release”
actions.
Approve and Release: The
Responsible Party of the
study needs to click on
“Approve” and “Release” for
the record to be sent to
ClinicalTrials.gov’s Quality
Assurance (QA) group for
review and to be published
on the ClinicalTrials.gov
website.
23
ClinicalTrials.gov QA
ClinicalTrials.gov does a manual review
•
•
•
If there are QA issues, the record owner and RP will
receive an email notification from ClinicalTrials.gov
with comments.
The study will be reset to “In Progress”. QA Comments
must be addressed and the RP must re-release the
record to ClinicalTrials.gov.
Once a record passes ClinicalTrials.gov’s QA review,
the study is assigned an NCT number and published
on the “public” side of the database.
Journal editors often request the NCT number as proof of
compliance with ICMJE requirements;
 The NCT number is often published in journal articles.

•
ClinicalTrials.gov review of registrations takes about
5-7 business days.
You may receive some QA comments if the record is lacking required information, or if the
information is not clear. The study registration will not receive an NCT number until these QA
comments are resolved. Your record is not officially registered until an NCT# is
assigned.
24
Published Registration
The searchable, public view of the database is at:
www.clinicaltrials.gov
25
Summary of Registration Process
1.
2.
Fill out Registration (“Create” a record)
Actions:
• In progress: Fields to be completed
• Completed: Ready for Approval and Release
• Approved/Released:
•
3.
4.
RP is sole party that can “Approve & Release”
ClinicalTrials.gov conducts QA review of record
Once it passes review, an NCT number is assigned
and the registration is posted on the public
ClinicalTrials.gov webpage
26
Maintaining a ClinicalTrials.gov record
•
•
•
Records must be updated every 6 months – unless Overall
Recruitment Status changes, then you should update the
record within 30 days.
Records must be updated within 30 days after the completion
date.
Failure to update information on ClinicalTrials.gov can result in
penalties
NOTE: ClinicalTrials.gov uses the “Record Verification Date” as the trigger for determining the next 6 month
update.
27
Updating Your Record
•
•
•
•
•
•
•
Log into ClinicalTrials.gov
Click on “Modify”
Click on “Edit” to open the study. Make
appropriate changes by clicking on “Edit” along
the side in the study record.
If no changes have occurred in the last 6
months, update the Record Verification Date by
clicking the “Edit” button next to the field.
Be sure click on “Complete” when finished
updating.
Study is ready for “Approval” and “Release”
Know who is responsible for “Approval” and
“Release” – The RP is responsible for Approval
and Release.
28
General Tips on Updating Your Record
• Complete all fields
• Use spelling tool for
spelling errors
(on the main protocol page, the third
tab to the right of “Main Menu”)
• Spell out acronyms and
abbreviations
• Use language that is easily
understood by the general
public for the Brief Title and
Brief Description.
• Use the EDIT links to make
changes or “Edit All” link at
top
• Check for errors and
warnings
• Check for notes (optional to
address)
29
29
Can a study record be deleted off of ClinicalTrials.gov?
•
Only if the study record
has never been released to
ClinicalTrials.gov
• Otherwise, no.
•
ClinicalTrials.gov serves as
a long-term public registry.
Once a study record is
published, it remains in the
system even after a trial
has closed.
•
If you find a duplicate,
contact ClinicalTrials.gov at
[email protected].
30
30
Checking your Problem Records
PRS System identifies current ‘Problem Records’:
•
•
•
•
Records that have not been marked as completed
Active studies that have not been updated in the past
6 months
Records missing one or more data elements required
by FDAAA, such as: Responsible Party, Study Start
Date, Primary Completion Date and Primary Outcome
Measure
Records that appear to be overdue for registration of
results per FDAAA
31
ClinicalTrials.gov – Help & User Guide
32
Additional Resources
•
•
•
•
•
•
•
•
ClinicalTrials.gov: How to Submit Studies:
http://clinicaltrials.gov/ct2/manage-recs
FDAAA related information:
http://clinicaltrials.gov/ct2/manage-recs/fdaaa
For specific questions or comments: [email protected].
Office of Extramural Research (OER):
http://grants.nih.gov/Clinicaltrials_fdaaa/
Frequently Asked Questions for NIH Grantees:
http://grants.nih.gov/Clinicaltrials_fdaaa/faq.htm
ICMJE FAQs: http://www.icmje.org/faq_clinical.html
Instructions for Authors sections of ICMJE journals all have
information regarding clinical trial registration
Contact your institution’s Clinical Trials Registration
Administrator via the Harvard Catalyst Regulatory
Atlas:http://connects.catalyst.harvard.edu/regulatoryatlas/?mo
de=c&id=50
33
This slide set was made possible by a collaboration of CTSA
organizations (Mayo Clinic, Partners HealthCare, University
of Michigan Medical School, University of Rochester) and
the National Library of Medicine.
The Clinical and Translational Science Awards Program
(CTSA) is part of the Roadmap Initiative, Re-Engineering
the Clinical Research Enterprise and is funded by the
National Center for Advancing Translational Sciences
(NCATS), National Institutes of Health (NIH).
34