October 2016
| * | Required by ClinicalTrials.gov |
| FDAAA | Required to comply with Food and Drug Administration Amendments Act (FDAAA), Section 801 |
| (FDAAA) | May be required to comply with FDAAA, Section 801 |
1. Study IdentificationBrief Title
*
FDAAA
Definition: Protocol title intended for the lay public.
(Limit: 300 characters)
Example: Safety Study of Recombinant Vaccinia Virus Vaccine to Treat Prostate Cancer
Acronym
Definition: Acronym or initials used to identify this study, if applicable.
Enter only the acronym. If supplied, the acronym is automatically displayed in parentheses following
the brief title.
(Limit: 14 characters)
Example:
Brief Title: Women's Health Initiative
Acronym: WHI
Displayed on ClinicalTrials.gov as: Women's Health Initiative (WHI)
Official Title
Definition: Official
name of the protocol provided by the study principal investigator or
sponsor.
Example: Phase 1 Study of Recombinant Vaccinia Virus That
Expresses Prostate Specific Antigen in Metastatic Adenocarcinoma of the
Prostate
(Limit: 600 characters)
Secondary IDs
FDAAA
Definition: Other identification numbers assigned to the protocol,
including unique identifiers from other registries
and NIH grant numbers, if applicable.
(Limit: 30 characters)
Study Type
*
FDAAA
Definition: Nature of the
investigation. Select one.
2. Study StatusRecord Verification Date
*
FDAAA
Definition:
Date the protocol information was last verified.
Verification date is shown along with organization name on ClinicalTrials.gov
to indicate to the public whether the information is being kept current,
particularly recruiting status and contact information.
Update verification date when reviewing the record for accuracy and
completeness, even if no other changes are made.
Overall Recruitment Status
*
FDAAA
[Required when Study Type is "Interventional" or "Observational".]
Definition: Overall accrual activity for the protocol. Select one.
NOTE: Contact information is shown on ClinicalTrials.gov only when overall status is "Recruiting" or "Not yet recruiting".
Why Study Stopped?
Definition: For suspended, terminated or withdrawn studies, provide a
brief explanation of why the study has been halted or terminated.
If desired, use brief summary or detailed description to provide additional information.
(Limit: 160 characters)
Study Start Date
FDAAA
Definition: Date that
enrollment to the protocol begins.
Primary Completion Date
FDAAA
[*
Required by ClinicalTrials.gov for records first released on or after December 1, 2012]
Definition: As specified in US Public Law 110-85, Title VIII, Section
801, with respect to an applicable clinical trial, the date that the
final subject was examined or received an intervention for the purposes
of final collection of data for the primary outcome, whether the
clinical trial concluded according to the prespecified protocol or was
terminated.
A "Type" menu is also included, with options Anticipated and
Actual. For active studies, set Type to Anticipated and specify the
expected completion date, updating the date as needed over the course of
the study. Upon study completion, change Type to Actual and update the
date if necessary.
Study Completion Date
Definition: Final date on which data was (or is expected to be)
collected.
Use the Type menu (Anticipated/Actual) as described above.
Expanded Access Status
*
Definition:
Status indicating availability of an experimental drug or device
outside any clinical trial protocol. This data element is only applicable for Expanded Access
records (see Expanded Access under Study Type). Select one.
3. Sponsor/CollaboratorsSponsor
*
FDAAA
Definition: Name of primary organization that oversees implementation of study and is
responsible for data analysis. For applicable clinical trials, sponsor is defined in 21 CFR 50.3.
(Limit: 160 characters)
Examples: National Institute of Allergy and Infectious Diseases, Bristol-Myers Squibb
Responsible Party
FDAAA
[*
Required by ClinicalTrials.gov for records first released on or after December 1, 2012]
Definition: As defined in US Public Law 110-85, Title VIII, Section 801,
the term "responsible party," with respect to a clinical trial, means
Investigator Information
If either Principal Investigator or Sponsor-Investigator is selected,
the following is required:
Collaborators
Definition: Other organizations (if any) providing support, including funding, design, implementation,
data analysis and reporting.
The data provider is responsible for confirming all collaborators
before listing them. Provide up to 10 full names of collaborating organizations.
(Limit: 160 characters per name)
4. Oversight
FDA Regulated Intervention?
(FDAAA)
Definition: Indicate whether this trial includes an intervention subject to US
Food and Drug Administration regulation under section 351 of the Public Health
Service Act or any of the following sections of the Federal Food, Drug
and Cosmetic Act: 505, 510(k), 515, 520(m), and 522. Select Yes/No.
Delayed Posting?
(FDAAA)
Definition: If this is a Section 801 applicable clinical trial,
indicate whether this trial includes a device NOT previously approved or cleared
by the US FDA for any use, as specified in US Public Law 110-85, Title VIII, Section 801.
Select Yes/No. If "Yes" is selected, full posting of the trial information
on ClinicalTrials.gov will be delayed until after the device has been approved or cleared.
At that time, it is the registrant's responsibility to change this selection to "No" and release
the record for full publication.
Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information: Complete the following only if the protocol involves an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) under US Food and Drug Administration regulations.
IND/IDE Protocol?
*
(FDAAA)
Definition: Indicate if the protocol involves an
Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) under US Food
and Drug Administration regulations (Will not be made public - for
administrative purposes only.)
IND/IDE Grantor
*
(FDAAA)
Definition: FDA center to which the IND
or IDE was submitted, i.e., Center for Drug Evaluation and Research (CDER) or Center for
Biologics Evaluation and Research (CBER) for INDs; Center for Devices and Radiological Health
(CDRH) for IDEs. Select one. (Will not be made public - for administrative purposes only.)
IND/IDE Number
*
(FDAAA)
Definition: Number assigned to an Investigational
New Drug Application (IND) or Investigational Device Exemption (IDE). (Will not be made public -
for administrative purposes
only.)
Examples: 22,333; BB1234
IND/IDE Serial Number
(FDAAA)
Definition: Use the serial number from the first
submission of the protocol to the IND or IDE. (Will not be made
public - for administrative purposes only.)
Has Expanded Access?
FDAAA
Definition: Indicate whether any non-protocol access is to be provided for the
investigational drug or device. If so, an Expanded Access record should also be
created for this IND/IDE.
Expanded Access Record
FDAAA
Definition: The ClinicalTrials.gov identifier (NCT number) for the Expanded Access record
associated with this study, specified if and only if "Yes" is specified for Has Expanded Access.
Review board information is desired but not required for trials associated with U.S. FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.
Review board information is required for internal administrative use and is not revealed to the public.
Board Approval * - provide information for only one review board, even for studies involving multiple boards
Oversight authority information is displayed on ClinicalTrials.gov. For IND/IDE protocols, Oversight Authority is filled in automatically with "United States: Food and Drug Administration."
5. Study Description
6. Conditions and KeywordsKeywords
Definition: Words or phrases that
best describe the protocol. Keywords help users find studies in the database.
Use NLM's Medical Subject Heading (MeSH) controlled vocabulary terms where
appropriate. Be as specific and precise as possible. Avoid acronyms and
abbreviations.
7. Study DesignN/A: for trials without phases (e.g., trials of devices or behavioral interventions)
Phase 0: exploratory trials, involving very limited human exposure, with no therapeutic or diagnostic intent (e.g., screening studies, microdose studies). See FDA guidance on exploratory IND studies for more information.
Phase 1: includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients
Phase 1/Phase 2: for trials that are a combination of phases 1 and 2
Phase 2: includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks
Phase 2/Phase 3: for trials that are a combination of phases 2 and 3
Phase 3: includes expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling
Phase 4: studies of FDA-approved drugs to delineate additional information including the drug's risks, benefits, and optimal use
If Single Blind or Double Blind is selected, check the role(s) that are to be masked: Subject, Caregiver, Investigator or Outcomes Assessor.
8. Arms, Groups and InterventionsArms: For interventional studies specify the arms, corresponding to Number of Arms specified under Study Design (for single-arm studies, the following data elements are optional).
Arm Label
*
(FDAAA)
- the short name used to identify the arm.
(Limit: 62 characters)
Examples:
Groups: For observational studies specify the predefined participant groups (cohorts) to be studied, corresponding to Number of Groups specified under Study Design (for single-group studies, the following data elements are optional). Do not use this section to specify strata (Detailed Description can be used for that purpose, if desired).
Interventions: For all studies, and for expanded access records, specify the associated intervention(s). For interventional studies, at least one intervention must be specified. For observational studies, specify the intervention(s)/exposure(s) of interest, if any.
For investigational new drugs that do not yet have a generic name, a chemical name, company code or serial number may be used on a temporary basis. As soon as the generic name has been established, update the associated protocol records accordingly.
For non-drug intervention types, provide an intervention name with sufficient detail
so that it can be distinguished from other similar interventions.
9. Outcome MeasuresPrimary Outcome Measure
FDAAA
[*
Required by ClinicalTrials.gov for records first released on or after December 1, 2012]
Definition: Specific key measurement(s) or observation(s) used to measure the effect of
experimental variables in a study, or for observational studies, to describe patterns of
diseases or traits or associations with exposures, risk factors or treatment.
Examples:
10. EligibilityMaximum Age
Definition: Maximum
age of participants. Provide a number and a unit of time (years, months,
weeks, days, hours or minutes). Select "N/A (No limit)" if no maximum age
is indicated.
11. Contacts, Locations, and Investigator InformationRecruitment Status
*
FDAAA
- protocol accrual activity at a facility. Select one.
Tip: When a trial's overall status changes to "Active, not recruiting," it is not necessary to change recruitment status for each location. Location recruitment status is only shown on ClinicalTrials.gov when Overall Status is "Recruiting".
Facility Contact
*
(FDAAA)
(or Central Contact required)
12. ReferencesDescription
Definition: title or
brief description of the linked page. If the page being linked is the
protocol's home page on the sponsor's Web site, include the words "Click
here for more information about this study:" and provide the name of the
protocol.
(Limit: 254 characters)
Examples: