| * | Required by ClinicalTrials.gov |
| FDAAA | Required to comply with US Public Law 110-85, Section 801 |
| (FDAAA) | May be required to comply with US Public Law 110-85, Section 801 |
1. Titles and Background Information
Secondary IDs
FDAAA
Definition: Other identification numbers assigned to the protocol,
including unique identifiers from other registries
and NIH grant numbers, if applicable.
Provide up to 5 Secondary ID Numbers, one per line.
Examples:
ISRCTN12345678
NCI-793-0115D
R01-123456-1
Brief Title
*
FDAAA
Definition: Protocol title intended for the lay public.
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.
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
Study Type
*
FDAAA
Definition: Nature of the
investigation. Select one.
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.
Section 801 Clinical Trial?
(FDAAA)
Definition: If this trial includes an FDA regulated intervention,
indicate whether this is an "applicable clinical trial" as defined in
US Public Law 110-85, Title VIII, Section 801. Briefly, applicable
drug trials include controlled clinical investigations, other than Phase I
investigations, of a drug or biologic subject to US FDA regulation.
Applicable device clinical trials are controlled trials with health
outcomes of devices subject to FDA regulation, other than small
feasibility studies, and pediatric postmarket surveillance. 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.
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 Status
*
Definition: Human subjects review board approval status. Select one.
Board Approval Number
*
(required only if status is "Submitted, approved")
Definition: Number assigned by the human subjects
review board upon approval of the protocol.
May be ommitted if status is anything other than approved.
If the human subjects review board does not assign numbers, please enter the date of approval in mm/dd/yyyy format.
Board Name
*
(required only if status is "Submitted, approved" or "Submitted, exempt")
Definition: Full name of the approving human subjects review board.
Example: National Institutes of Health - NCI - IRB #1
Board Affiliation
*
(required only if status is "Submitted, approved" or "Submitted, exempt")
Definition: Official name of organizational affiliation of
the approving human subjects review board.
Example: US National Institutes of Health
Board Contact
*
(required only if status is "Submitted, approved" or "Submitted, exempt")
Definition: Contact information for the human subjects review board.
Data Monitoring Committee?
Definition: Indicate whether a data monitoring committee has
been appointed for this study.
The data monitoring committee (board) is a group of independent
scientists who are appointed to monitor the safety and scientific
integrity of a human research intervention, and to make recommendations
to the sponsor regarding the stopping of the trial for efficacy, for
harms or for futility. The composition of the committee is
dependent upon the scientific skills and knowledge required for
monitoring the particular study.
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."
Oversight Authorities
*
Definition: The name of each national or international health organization with authority over the protocol.
Use the following format for each authority:
country: organization name
Examples:
United States: Institutional Review Board
United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Australia: Therapeutic Goods Administration
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.
Responsible Party
FDAAA
Definition: As defined in US Public Law 110-85, Title VIII, Section 801,
the term "responsible party", with respect to a clinical trial, means
Provide the following information for the designated responsible party:
Detailed Description
Definition: Extended description of the protocol, including more
technical information (as compared to the Brief Summary) if desired.
Do not include the entire protocol; do not duplicate information
recorded in other data elements, such as eligibility criteria or
outcome measures.
Example:
Sudden out-of-hospital cardiac arrest (OOH-CA) remains a significant cause of death,
in spite of recent declines in overall mortality from cardiovascular disease. Existing methods of emergency
resuscitation are inadequate due to time delays inherent in the transport of a trained responder with
defibrillation capabilities to the side of the OOH-CA victim. Existing Emergency Medical Services (EMS)
systems typically combine paramedic Emergency Medical Technician (EMT) services with some level of community
involvement, such as bystander cardiopulmonary resuscitation (CPR) training. Some communities include automated
external defibrillators (AEDs) at isolated sites or in mobile police or fire vehicles. A comprehensive, integrated
community approach to treatment with AEDs would have community units served by these volunteer non-medical responders
who can quickly identify and treat a patient with OOH-CA. Such an approach is termed Public Access Defibrillation (PAD).
Record 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
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.
Study Start Date
FDAAA
Definition: Date that
enrollment to the protocol begins.
Primary Completion Date
FDAAA
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
FDAAA
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.
Study Phase
*
FDAAA
Definition: Phase of investigation,
as defined by the US FDA
for trials involving investigational new drugs.
Select only one.
N/A: for trials without phases
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
Intervention Model
(FDAAA)
(at least one of the following required: Intervention Model, Masking, Allocation.
All may be required as part of Study Design under PL 110-85, Section 801)
- intervention assignments
Number of Arms
(FDAAA)
Definition: Number of intervention groups (enter 1 for single-arm study).
Masking
(FDAAA)
(at least one of the following required: Intervention Model, Masking, Allocation.
All may be required as part of Study Design under PL 110-85, Section 801)
- knowledge of intervention assignments
If Single Blind or Double Blind is selected, check the role(s) that are to be masked: Subject, Caregiver, Investigator or Outcomes Assessor.
Allocation
(FDAAA)
(at least one of the following required: Intervention Model, Masking, Allocation.
All may be required as part of Study Design under PL 110-85, Section 801)
- participant assignment to intervention group
Study Classification (formerly Endpoint) - type of primary outcome or endpoint that the protocol is designed to evaluate. Select one.
Enrollment (Target or Actual Number of Subjects)
FDAAA
Definition: Number of subjects in the trial.
A "Type" menu is also included, with options Anticipated and Actual.
For active studies, set Type to Anticipated and specify the expected enrollment,
updating the number as needed over the course of the study. Upon study completion,
change Type to Actual and update the enrollment if necessary.
Time Perspective
* - temporal relationship of observation period
to time of subject enrollment. Select one.
Biospecimen Retention - select one
Biospecimen Description
Definition: Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).
Enrollment
*
Definition: (see above)
Number of Groups/Cohorts
*
Definition: Number of study groups/cohorts. Enter 1 for a single-group study.
Many observational studies have one group/cohort; case control studies typically have two.
Primary and Secondary Outcome Measures
NOTE: When Results are added to a record, outcome measures are transferred from the protocol section to the results section.
Primary Outcome Measure
FDAAA
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:
Secondary Outcome Measures
FDAAA
Definition:
Other key measures that will be used to evaluate the
intervention(s) or, for observational studies, that are a focus of the study.
Specify Outcome Measure, Time Frame and Safety Issue (see above).
For interventional studies specify the arms:
Arm Label
*
(FDAAA)
- the short name used to identify the arm.
Examples:
Arm Type * (FDAAA) - select one
Arm Description (FDAAA) - brief description of the arm. This element may not be necessary if the associated intervention descriptions contain sufficient information to describe the arm.
For observational studies specify the predefined participant groups (cohorts) to be studied. Do not use this section to specify strata (Detailed Design can be used for that purpose, if desired).
Group/Cohort Label
*
- the short name used to identify the group.
Examples:
Group/Cohort Description Definition: Explanation of the nature of the study group (e.g., those with a condition and those without a condition; those with an exposure and those without an exposure). Note that the overall study population should be described under Eligibility.
For all studies, and for expanded access records, specify the associated intervention(s).
Intervention Name * FDAAA - for drugs use generic name; for other types of interventions provide a brief descriptive name.
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.
Intervention Description
(FDAAA)
- cover key details of the intervention.
Must be sufficiently detailed to distinguish between arms of a study
(e.g., comparison of different dosages of drug) and/or among similar
interventions (e.g., comparison of multiple implantable cardiac
defibrillators). For example, interventions involving drugs may
include dosage form, dosage, frequency and duration.
Example:
50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number
of Cycles: until progression or unacceptable toxicity develops.
Arms/Groups * (FDAAA) - if arms or groups have been specified for the protocol, select the ones for which the intervention is to be administered. For interventional studies with arms specified, all arms must have at least one intervention (unless arm type is "No Intervention") and each intervention must be assigned to at least one arm. For observational studies with groups specified, each intervention (if any) must be assigned to at least one group.
Other Names - list other names used to identify the intervention, past or present (e.g., brand name for a drug). These names will be used to improve search results in ClinicalTrials.gov.
Keywords
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.
Sampling Method * - For observational studies only, select one and explain in Detailed Description.
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- Must be able to swallow tablets
Exclusion Criteria:
- Insulin dependent diabetes
- Thyroid disease
Gender
*
FDAAA
Definition: Physical gender
of individuals who may participate in the protocol. Select one.
Age Limits * FDAAA
Maximum 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.
Accepts Healthy
Volunteers?
FDAAA
Definition: Indicate if persons who have not had the
condition(s) being studied or otherwise related conditions or symptoms, as
specified in the eligibility requirements, may participate in the study.
Select Yes/No.
11. Protocol Location, Contact and Investigator Information
Multiple locations may be specified. Location is composed of the following fields.
Recruitment Status
*
FDAAA
- protocol accrual activity at a facility. Select one.
NOTE: Contact information is shown on ClinicalTrials.gov only for locations with status set to "Recruiting" or "Not yet recruiting".
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)
Facility Contact Backup
Person
to contact if Facility Contact is not available (i.e., a second contact
person).
Investigators (at the
protocol location)
Central Contact
*
(FDAAA)
(or Facility Contact required)
Definition:
Person providing centralized, coordinated recruitment information for the
entire study.
Central Contact
Backup
Person to contact if Central Contact is not
available.
Overall Study Officials
Definition: Person(s) responsible for the overall
scientific leadership of the protocol, including study principal investigator.
12. Related Information
Citation
Definition: bibliographic
reference in NLM's MEDLINE format
Example: Barza M; Pavan PR; Doft BH;
Wisniewski SR; Wilson LA; Han DP; Kelsey SF. Evaluation of microbiological
diagnostic techniques in postoperative endophthalmitis in the
Endophthalmitis Vitrectomy Study. Arch Ophthalmol 1997 Sep;115(9):1142-50
Description
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.
Examples: