ClinicalTrials gov Data Element Definition - DRAFT _2-5-08_

ClinicalTrials.gov Data Element Definitions (DRAFT)
February 5, 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:
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
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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, single-patient 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, 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

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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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(FDAAA)
IND/IDE Grantor
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). (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

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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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- provide information for only one review board, even for studies
Board Approval
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, approved")
Board Approval Number
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

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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.
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

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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:
Name/Official Title FDAAA - for either the principal investigator or sponsor contact
Organization FDAAA - 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
o
o

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

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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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FDAAA
Record Verification Date
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.

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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.

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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.
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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.

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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.
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
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 11085, 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 11085, 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
Bio-equivalence: scientific basis for comparing generic and brand name
drugs

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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
Observational Study Model
follow-up. Select one.
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* - primary strategy for subject identification and

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

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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
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:
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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 noninvestigational 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:

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Arm Number or Label (FDAAA) - the number, letter or name used to identify
the arm. Examples: A, 2, III
Arm Type
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(FDAAA)

- select one

Experimental
Active Comparator
Placebo Comparator
Sham Comparator
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).

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- the number, letter or name used to identify
Group/Cohort Number or Label
the group. Examples: A, 2, III, Surgical, Observation
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
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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 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)
- if arms or groups have been specified for the protocol,
Arms/Groups
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.

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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).
Sampling Method
Description.
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* - For observational studies only, select one and explain in Detailed

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.
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)

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

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City

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State/Province
Postal Code

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Country

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(FDAAA)

*

*

(FDAAA)

(FDAAA)

Recruitment Status

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FDAAA

- protocol accrual activity at a facility. Select one.

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•
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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 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

17

•

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)

*

•

(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

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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.
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 non-profit 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

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