ClinicalTrials

ClinicalTrials.gov Protocol Data Element Definitions

August 20, 2008

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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

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Organization's Unique Protocol ID FDAAA
Definition: Unique identification assigned to the protocol by the sponsoring
organization, usually an accession number or a variation of a grant number.
Multiple studies conducted under the same grant must each have a unique
number.
Examples:
ABT-1233-RV
Merck-023
ACTG 021
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

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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:

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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

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FDAAA
Study Type
Definition: Nature of the investigation. Select one.

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Interventional: studies in human beings in which individuals are assigned
by an investigator 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.
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.
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, singlepatient IND, treatment IND, compassionate use, emergency use, continued
access and parallel track.

2. US Food and Drug Administration (FDA) Information
Applicable Clinical Trial
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,

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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.

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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.)

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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.)

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(FDAAA)
IND/IDE Number
Definition: Number assigned to an Investigational New Drug
Application (IND) or Investigational Device Exemption (IDE).

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(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.
3. Human Subjects Review Submitted studies must have approval from a human
subjects review board prior to the recruitment of the first patient. Appropriate review
boards include an Institutional Review Board, an ethics committee or an equivalent group
that is responsible for review and monitoring of this protocol to protect the rights and
welfare of human research subjects. A study may be submitted for registration prior to
approval of the review board so long as the study is not yet recruiting patients.
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.

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Board Approval
- provide information for only one review board, even for
studies involving multiple boards

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Board Approval Status
Definition: Human subjects review board approval status. Select one.
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Request not yet submitted: review board approval is required but
has not yet been requested
Submitted, pending: review board approval has been requested but
not yet granted
Submitted, approved: review board approval has been requested
and obtained
Submitted, exempt: review board has granted an exemption in
response to the approval request
Submitted, denied: review board has denied the approval request
Submission not required: the study does not require human
subjects review

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(required only if status is "Submitted,
Board Approval Number
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.

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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

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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

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Board Contact
(required only if status is "Submitted, approved" or
"Submitted, exempt")
Definition: Contact information for the human subjects review board.
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Phone (or Email required): Use the format 123-456-7890 within the
United States and Canada. Otherwise, provide the country code.
Ext: Phone extension, if needed

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Email (or Phone required): Electronic mail address.
Address: Mailing address for the board, including street address, city, state
or province, postal code, and country.

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.

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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."

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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
4. Sponsors

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FDAAA
Sponsor
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.
Examples: National Institute of Allergy and Infectious Diseases, Bristol-Myers
Squibb

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
1. the sponsor of the clinical trial (as defined in 21 CFR 50.3) or
2. the principal investigator of such clinical trial if so designated by a
sponsor, grantee, contractor, or awardee, so long as the principal
investigator is responsible for conducting the trial, has access to and
control over the data from the clinical trial, has the right to publish the
results of the trial, and has the ability to meet all of the requirements for
the submission of clinical trial information.
Provide the following information for the designated responsible party:

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Name/Official Title FDAAA - for either the principal investigator or sponsor
contact
FDAAA
o Organization
- the sponsor or the principal investigator's
organizational affiliation
FDAAA
o Contact Information
- [required for internal administrative use
only; not revealed to public] provide telephone number and/or email
address
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5. Study Description

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Brief Summary FDAAA
Definition: Short description of the protocol intended for the lay public. Include a
brief statement of the study hypothesis.
Example: The purpose of this study is to determine whether prednisone,
methotrexate, and cyclophosphamide are effective in the treatment of rapidly
progressive hearing loss in both ears due to autoimmune inner ear disease
(AIED).
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).
6. Status

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Record Verification Date FDAAA
Definition: Date the protocol information was last verified. Verification date is

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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.

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FDAAA
Overall Recruitment Status
Definition: Overall accrual activity for the protocol. Select one.

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Not yet recruiting: participants are not yet being recruited
Recruiting: participants are currently being recruited
Enrolling by invitation: participants are being (or will be) selected from a
predetermined population
Active, not recruiting: study is ongoing (i.e., patients are being treated or
examined), but participants are not currently being recruited or enrolled
Completed: the study has concluded normally; participants are no longer
being examined or treated (i.e., last patient's last visit has occurred)
Suspended: recruiting or enrolling participants has halted prematurely but
potentially will resume
Terminated: recruiting or enrolling participants has halted prematurely and
will not resume; participants are no longer being examined or treated
Withdrawn: study halted prematurely, prior to enrollment of first
participant

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.

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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.
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Available: expanded access is currently available for this treatment.
No longer available: expanded access was available for this treatment
previously but is not currently available and will not be available in the
future.
Temporarily not available: expanded access is not currently available for
this treatment, but is expected to be available in the future.
Approved for marketing: this treatment has been approved for sale to the
public.

7. Study Design

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Interventional Study Design (FDAAA)
Definition: Primary investigative techniques used in the protocol. Select the most
appropriate term describing the protocol from each of the following data
elements.
Primary Purpose FDAAA - reason for the protocol
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Treatment: protocol designed to evaluate one or more interventions
for treating a disease, syndrome or condition
Prevention: protocol designed to assess one or more interventions
aimed at preventing the development of a specific disease or health
condition
Diagnostic: protocol designed to evaluate one or more
interventions aimed at identifying a disease or health condition
Supportive Care: protocol designed to evaluate one or more
interventions where the primary intent is to maximize comfort,
minimize side effects or mitigate against a decline in the subject's
health or function. In general, supportive care interventions are not
intended to cure a disease.
Screening: protocol designed to assess or examine methods of
identifying a condition (or risk factors for a condition) in people
who are not yet known to have the condition (or risk factor).
Health Services Research: protocol designed to evaluate the
delivery, processes, management, organization or financing of
health care.
Basic Science: protocol designed to examine the basic mechanism
of action (e.g., physiology, biomechanics) of an intervention.

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Other: describe in Detailed Description.

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FDAAA
Study Phase
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
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Single Group: single arm study
Parallel: participants are assigned to one of two or more groups in
parallel for the duration of the study

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Cross-over: participants receive one of two alternative
interventions during the initial phase of the study and receive the
other intervention during the second phase of the study
Factorial: two or more interventions, each alone and in
combination, are evaluated in parallel against a control group

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
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Open: no masking is used. All involved know the identity of the
intervention assignment.
Single Blind: one party, either the investigator or participant, is
unaware of the intervention assignment; also called single-masked
study.
Double Blind: two or more parties are unaware of the intervention
assignment
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
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N/A: single arm study
Randomized Controlled Trial: participants are assigned to
intervention groups by chance
Nonrandomized Trial: participants are expressly assigned to
intervention groups through a non-random method, such as
physician choice

Study Classification (formerly Endpoint) - type of primary outcome or
endpoint that the protocol is designed to evaluate. Select one.
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N/A: not applicable
Safety: show if the drug is safe under conditions of proposed use
Efficacy: measure of an intervention's influence on a disease or
health condition
Safety/Efficacy

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Bio-equivalence: scientific basis for comparing generic and brand
name drugs
Bio-availability: rate and extent to which a drug is absorbed or
otherwise available to the treatment site in the body
Pharmacokinetics: the action of a drug in the body over a period of
time including the process of absorption, distribution and
localization in tissue, biotransformation, and excretion of the
compound
Pharmacodynamics: action of drugs in living systems
Pharmacokinetics/dynamics

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.
Observational Study Design

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Observational Study Model - primary strategy for subject
identification and follow-up. Select one.
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Cohort: group of individuals, initially defined and composed, with
common characteristics (e.g., condition, birth year), who are
examined or traced over a given time period
Case-control: group of individuals with specific characteristics
(e.g., conditions or exposures) compared to group(s) with different
characteristics, but otherwise similar
Case-only: single group of individuals with specific characteristics
Case-crossover: characteristics of case immediately prior to
disease onset (sometimes called the hazard period) compared to
characteristics of same case at a prior time (i.e., control period)
Ecologic or community studies: geographically defined
populations, such as countries or regions within a country,
compared on a variety of environmental (e.g., air pollution
intensity, hours of sunlight) and/or global measures not reducible
to individual level characteristics (e.g., health care system, laws or
policies median income, average fat intake, disease rate)
Family-based: studies conducted among family members, such as
genetic studies within families or twin studies and studies of family
environment
Other - explain in Detailed Description

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Time Perspective - temporal relationship of observation period to time
of subject enrollment. Select one.
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Prospective: look forward using periodic observations collected
predominantly following subject enrollment
Retrospective: look back using observations collected
predominantly prior to subject selection and enrollment
Cross-sectional: observations or measurements made at a single
point in time, usually at subject enrollment
Other - explain in Detailed Description

Biospecimen Retention - select one
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None Retained - no samples retained
Samples With DNA - samples retained, with potential for
extraction of DNA from at least one of the types of samples
retained (e.g., frozen tissue, whole blood)
Samples Without DNA - samples retained, with no potential for
DNA extraction from any retained samples (e.g., fixed tissue,
plasma)

Biospecimen Description
Definition: Specify all types of biospecimens to be retained (e.g., whole
blood, serum, white cells, urine, tissue).

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Enrollment
Definition: (see above)

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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.

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Outcome Measure FDAAA - The specific measure that will be used
to determine the effect of the intervention(s) or, for observational
studies, related to core objectives of the study and receiving the
most emphasis in assessment.
Time Frame (FDAAA) - Time point(s) at which outcome measure is
assessed.
Safety Issue? (FDAAA) - Is this outcome measure assessing a safety
issue? Select: Yes/No

Examples:
Outcome Measure: all cause mortality
Time Frame: one year
Safety Issue: No
Outcome Measure: Evidence of clinically definite ischemic stroke
(focal neurological deficits persisting for more than 24 hours)
confirmed by non-investigational CT or MRI
Time Frame: within the first 30 days (plus or minus 3 days) after
surgery
Safety Issue: Yes
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).
8. Arms, Groups and Interventions
For interventional studies specify the arms:
Arm Label
Examples:
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(FDAAA)

- the short name used to identify the arm.

Metformin
Lifestyle counseling
Sugar pill

Arm Type
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(FDAAA)

- select one

Experimental
Active Comparator
Placebo Comparator
Sham Comparator

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•
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No intervention
Other

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
Examples:
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* - the short name used to identify the group.

Statin dose titration
Chronic kidney disease, no anemia
No treatment

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 Type
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FDAAA

- select one per intervention

Drug (including placebo)
Device (including sham)
Biological/Vaccine
Procedure/Surgery
Radiation
Behavioral (e.g., Psychotherapy, Lifestyle Counseling)
Genetic (including gene transfer, stem cell and recombinant DNA)
Dietary Supplement (e.g., vitamins, minerals)
Other

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FDAAA
Intervention Name
- 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

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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.

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(FDAAA)
Arms/Groups
- 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.
9. Conditions and Keywords

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FDAAA
Conditions or Focus of Study
Definition: Primary disease or condition being studied, or focus of the study.
Diseases or conditions should use the National Library of Medicine's Medical
Subject Headings (MeSH) controlled vocabulary when possible.

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.
10. Eligibility

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Study Population Description
Definition: For observational studies only, a description of the population from
which the groups or cohorts will be selected (e.g., primary care clinic, community
sample, residents of a certain town).

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Sampling Method - For observational studies only, select one and explain in
Detailed Description.
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Probability Sample: exclusively random process to guarantee that each
participant or population has specified chance of selection, such as simple
random sampling, systematic sampling, stratified random sampling,
cluster sampling, and consecutive patient sampling
Non-Probability Sample: any of a variety of other sampling processes,
such as convenience sampling or invitation to volunteer

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Eligibility Criteria FDAAA
Definition: Summary criteria for participant selection. The preferred format
includes lists of inclusion and exclusion criteria as shown below.
Example:
Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- Must be able to swallow tablets
Exclusion Criteria:
- Insulin dependent diabetes
- Thyroid disease

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Gender FDAAA
Definition: Physical gender of individuals who may participate in the protocol.
Select one.
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Both: both female and male participants are being studied
Female: only female participants are being studied
Male: only male participants are being studied

Age Limits

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FDAAA

Minimum Age
Definition: Minimum age of participants. Provide a number and select a
unit of time (years, months, weeks, days, hours or minutes). Select "N/A
(No limit)" if no minimum age is indicated.

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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.
Facility

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(FDAAA)

•

Name: Full name of the organization where the protocol is being
conducted.
Examples: UCLA Eye Institute; Springfield Memorial Hospital

•

City

•
•

State/Province
Postal Code

•

Country

*

(FDAAA)

*

•
•
•
•
•

(FDAAA)

(FDAAA)

Recruitment Status
•
•
•

*

*

FDAAA

- protocol accrual activity at a facility. Select one.

Not yet recruiting: participants are not yet being recruited
Recruiting: participants are currently being recruited
Enrolling by invitation: participants are being (or will be) selected from a
predetermined population
Active, not recruiting: study is ongoing (i.e., patients are being treated or
examined), but participants are not currently being recruited or enrolled
Completed: the study has concluded normally; participants are no longer
being examined or treated (i.e., last patient's last visit has occurred)
Suspended: recruiting or enrolling participants has halted prematurely but
potentially will resume
Terminated: recruiting or enrolling participants has halted prematurely and
will not resume; participants are no longer being examined or treated
Withdrawn: study halted prematurely, prior to enrollment of first
participant

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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)

•
•

First Name
Middle Initial

•

Last Name
Degree

•
•

•
•

*

(or Central Contact required)

(FDAAA)

*

(FDAAA)
Phone
: (or Email required) office phone of the facility contact
person. Use the format 123-456-7890 within the United States and
Canada. Otherwise, provide the country code.
Ext: phone extension, if needed

*

(FDAAA)
Email
: (or Phone required) electronic mail address of the
facility contact person

Facility Contact Backup
Person to contact if Facility Contact is not available (i.e., a second contact
person).
Investigators (at the protocol location)
•
•
•
•
•

First Name
Middle Initial
Last Name
Degrees
Role: Site Principal Investigator or Site Sub-Investigator (pick one)

*

Central Contact (FDAAA) (or Facility Contact required)
Definition: Person providing centralized, coordinated recruitment information for
the entire study.
•
•

First Name
Middle Initial

•

Last Name
Degree

•

*

(FDAAA)

19

*

•

(FDAAA)
Phone
: Toll free phone number of the central contact. person.
Use the format 800-555-5555 within the United States and Canada.
Otherwise, provide the country code.
Ext: phone extension, if needed

•

Email

•

*

(FDAAA)

: electronic mail address of the central contact person

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.
•
•
•
•
•
•

First Name
Middle Initial
Last Name
Degree
Official's Role: Position or function of the official. Select one (Study
Chair/Study Director/Study Principal Investigator).
Organizational Affiliation: Full name of the official's organization. If
none, specify Unaffiliated.

12. Related Information
References
Definition: Citations to publications related to the protocol: background and/or
results. Provide either the unique PubMed Identifier (PMID) of an article or enter
the full bibliographic citation.
MEDLINE Identifier
Definition: unique PubMed Identifier (PMID) for the citation in
MEDLINE
Example: PMID: 10987815
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
Results Reference?
Definition: Indicate if the reference provided reports on results from this
clinical research study.

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Links
Definition: A Web site directly relevant to the protocol may be entered, if desired.
Do not include sites whose primary goal is to advertise or sell commercial
products or services. Links to educational, research, government, and other nonprofit Web pages are acceptable. All submitted links are subject to review by
ClinicalTrials.gov.
URL
Definition: complete URL, including http://
Example: http://www.alzheimers.org/
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:
Click here for more information about this study: Clinical Trial of
Eye Prophylaxis in the Newborn
The Alzheimer's Disease Education and Referral (ADEAR) Center
is a service of the National Institute on Aging

21