ClinicalTrials.gov Definitions

This page defines the data fields that are submitted to ClinicalTrials.gov for interventional studies (clinical trials) and observational studies. These definitions are mostly adapted from 42 CFR Part 11.

Name of Field: Unique Protocol ID
Definition: Enter in the Rascal IRB protocol # (i.e., AAAX####).

Name of Field: Brief Title
Definition: Include an abbreviated title for the study, but do not include study design terms (e.g., Phase I, randomized, double-blinded).

Name of Field: Official Title
Definition: Include the official IRB-approved title of the study.

Name of Field: Secondary ID
Definition: If the study is being funded by an external source (e.g., NIH), enter the grant # in this field and include the funding source under "Collaborator field".

Name of Field: Record Verification
Definition: Enter the last time the information on the ClinicalTrials.gov record was reviewed. This field should be updated once every year, at minimum.

Name of Field: Overall Status
Definition: Enter the current status of the study, which should be in line with the IRB Board Status.

Name of Field: Study Start
Definition: Enter the date of when the first participant signed or is expected to sign a study consent form. This field does not correspond to the initial IRB approval date.

Name of Field: Primary Completion
Definition: Enter the date of when all data collection is complete to address the primary outcome measure(s). This usually corresponds with the last date of interaction (can be in-person or remote visits, telephone communication, email communication, etc.).

Name of Field: Study Completion
Definition: Enter the date of when all data collection is complete to address secondary and any other pre-specified outcome measures, along with safety data. This usually corresponds with the last date of interaction (can be in-person or remote visits, telephone communication, email communication, etc.).

Name of Field: Sponsor
Definition: This field will always be pre-populated to say "Columbia University" unless "Sponsor-Investigator" is selected as the Responsible Party.

Name of Field: Responsible Party
Definition: For Applicable Clinical Trials (ACTs) and NIH-funded trials, select "Principal Investigator" or "Sponsor-Investigator".

Name of Field: Collaborators
Definition: List all sources of support or collaboration, as identified in the IRB "Support Information" section of the Rascal submission. If the full name is not recognized, click on the "Recognize" button at the bottom. For multicenter research, sub-sites will be listed in the Contacts/Locations section of the record.

Name of Field: U.S. FDA-regulated Drug
Definition: Enter "YES" if one or more drug or biologic products that are regulated by the FDA (could be already approved and marketed) are being studied.

Name of Field: U.S. FDA-regulated Device
Definition: Enter "YES" if one or more device products that are regulated by the FDA (could be already approved or cleared for marketing) are being studied.

Name of Field: U.S. FDA IND/IDE
Definition: Enter "YES" if you are studying the product under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application with the FDA.

Name of Field: Human Subjects Review
Definition: Board Status: Select the most current board status (should match Rascal).

For CUIMC:

Board Name: CUIMC IRB 1, 2, 3, 4, 5 or Exp
Board Affiliation: Columbia University Irving Medical Center
Phone Number: 212-305-5883
Email: [email protected]
Address: 154 Haven Avenue, 2nd Floor
New York, NY 10032

For Morningside:

Board Name: Columbia University MS IRB Board Affiliation: Columbia University Morningside
Phone: (212) 851-7040
Email: [email protected]
Address: 615 West 131st Street, Floors 3 and 6
New York, NY 10027

Name of Field: Data Monitoring
Definition: Enter "YES" if you have a Data and Safety Monitoring Board/Committee designated for the study.

Name of Field: FDA Regulated Intervention
Definition: Enter "YES" if studying a drug, device or biologic product that is subject to FDA regulations.

Section 801 Clinical Trial: If answered as "YES", indicate whether this study meets the Section 801 criteria (i.e., Applicable Clinical Trial)
Click here for ACT checklist.

Name of Field

Brief Summary

Definition

Provide a short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in lay language intended for the public.

TIPS:

Do not include personal pronouns such as “I, we, our, us, they, them, their, you or yours”; it should be rewritten to say "the investigators" or "the subjects".
Do not include duplicate information that is found in other data elements and fields.
Do not include references.
Include full sentences and check for spelling and formatting errors.
Expand all acronyms at first use.
Use the "Spelling" link at the top of the record to search for spelling errors.
Keep the language simple and easy to understand.

Name of Field

Detailed Description

Definition

Provide background information on why the study is being conducted.

TIPS:

Do not include personal pronouns such as “I, we, our, us, they, them, their, you or yours”; it should be rewritten to say "the investigators" or "the subjects".
Do not include duplicate information that is found in other data elements and fields.
Do not include references.
Include full sentences and check for spelling and formatting errors.
Expand all acronyms at first use.
Use the "Spelling" link at the top of the record to search for spelling errors.
Keep the language simple and avoid using scientific or technical terminology that is too complicated.

Name of Field

Conditions

Definition

List the name(s) of the disease(s) or condition(s) studied in the clinical study, or the focus of the clinical study.

TIPS:

Do not use verbs or complete sentences.
List each condition individually, one per line.
Use Search MeSH, the National Library of Medicine's Medical Subject Headings, to search for valid condition terms.

Name of Field

Keywords

Definition

List words or phrases that best describe the protocol. These keywords help users find studies in the database.

TIPS:

Keywords should not be numbered or bulleted.
List each keyword individually, one per line.

Interventional

Name of Field: Study Type
Definition: Select "Interventional".

Name of Field

Primary Purpose

Definition

Select the main objective of the intervention(s) being studied:

Treatment: One or more intervention(s) are being studied for treating a disease or condition.
Prevention: One or more intervention(s) are being studied for preventing the development of a disease or condition.
Diagnostic: One or more intervention(s) are being evaluated for identifying a disease or condition.
Supportive Care: One or more intervention(s) are being evaluated for maximizing comfort, minimizing side effects, or mitigating against a decline in health or function.
Screening: One or more intervention(s) are assessed or examined for 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: One or more intervention(s) for evaluating the delivery, processes, management, organization, or financing of healthcare.
Basic Science: One or more intervention(s) for examining the basic mechanism of action.
Device Feasibility: Device product being evaluated in a small clinical trial (usually <10 subjects) to determine the feasibility of the product.
Other: None of the other options apply.

Name of Field: Study Phase
Definition: For clinical trials of drug products, select from Early Phase 1 to Phase 4.

For clinical trials with device products or behavioral interventions, select "N/A".

Name of Field

Interventional Study Model

Definition

Select the correct strategy for assigning interventions to subjects.

Single Group: All subjects are treated in a single arm.
Parallel: Subjects are assigned to 1 of 2 or more groups in parallel for the study.
Crossover: Subjects receive 1 of 2 or more interventions during the initial phase of the study and then 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.
Sequential: Groups of subjects are assigned to receive interventions based on prior milestones being reached in the study (e.g., dose escalation).

Name of Field: Model Description
Definition: Provide details about the interventional study model.

Name of Field: Number of Arms
Definition: Enter the number of arms in the clinical trial.

Name of Field: Masking
Definition: Define who, if any, are blinded to the intervention assignment.

Select "no masking" if the study only includes 1 arm or is open-label.

Name of Field: Masking Description
Definition: Provide information on who may be blinded to the intervention assignment.

Name of Field: Allocation
Definition: Select the method by which subjects are assigned to the arms of a clinical trial.

Select "N/A" if the study only includes 1 arm or is open-label.

Name of Field: Enrollment
Definition: When the study has not yet begun or is still ongoing, enter the estimated number of subjects to be enrolled (i.e., target enrollment).

When the study has completed, enter the actual number of subjects enrolled. For studies that are marked as "withdrawn" in PRS, the actual number of enrolled subjects should be 0.

NOTE: "Enrolled" should include any individual who signs a study consent form to participate in a study.

Observational

Name of Field: Study Type
Definition: Select "Observational".

Name of Field

Observational Study Model

Definition

Select the primary strategy for subject identification and follow-up:

Cohort: Group of individuals with common characteristics who are examined or studied over a period of time.
Case-Control: Group of individuals with specific characteristics (e.g., same condition or exposure) 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 compared to characteristics of same case at a prior time.
Ecologic or Community Studies: Geographically defined populations, such as countries or regions within a country, compared on a variety of environmental and/or global measures.
Family-Based: Studies conducted among family members, such as genetic studies within families or twin studies.
Other: Explain.

Name of Field

Time Perspective

Definition

Select the correct observational period from the time of subject enrollment.

Retrospective: Looking at observations that were collected prior to enrollment.
Prospective: Looking at observations that will be collected after subjects are enrolled.
Cross-sectional: Looking at observations or measurements made at a single point in time, usually at subject enrollment.
Other: Explain.

Name of Field: Biospecimen Retention
Definition: Indicate whether any samples of material from research subjects are collected and retained in a biorepository.

Name of Field: Biospecimen Description
Definition: Specify all types of biospecimen(s) to be retained (e.g., whole blood, serum, urine, tissue).

Name of Field: Enrollment
Definition: Enter the estimated total number of subjects to be enrolled or the actual number of subjects that are enrolled.

Name of Field: Target Follow-Up Duration
Definition: For patient registries, enter the anticipated time period over which each subject is followed. This should be entered as a number with a unit of time (e.g., years, months, weeks, days).

Name of Field: Number of Groups/Cohorts
Definition: Enter the number of study groups/cohorts. For single-group studies, enter "1".

NOTE: Many observational studies have 1 group/cohort and case control studies typically have 2.

Arms (Interventional)

Name of Field: Arm Title
Definition: Enter a short descriptive name for the arm.

NOTE: There is a limit of 100 characters in this field so the arm title should be short but descriptive enough to identify each individual arm.

Name of Field

Arm Type

Definition

Select the role of each arm in the clinical trial:

Experimental
Active Placebo Comparator (drug studies)
Sham Comparator (device or procedure studies)
No Intervention (i.e., standard treatment with no intervention(s))
Other

Name of Field: Arm Description
Definition: Enter a description of each arm of the clinical trial and include its role in the study (e.g., placebo or control), inclusive of which interventions, if any, are administered in each arm.

Groups/Cohorts (Observational)

Name of Field: Group/Cohort Label
Definition: Enter a short descriptive name to identify the group.

NOTE: There is a limit of 100 characters in this field so the title should be short but descriptive enough to identify each individual group/cohort.

Name of Field: Group/Cohort Description
Definition: Enter a description of the study group/cohort that includes the specific population to be studied. If exposed to a condition or intervention, include it in this summary.

Intervention(s)

Name of Field

Intervention Type

Definition

For each intervention, select the type of intervention being studied:

Drug (including placebo)
Device (including sham)
Biological/Vaccine
Procedure/Surgery
Radiation
Behavioral (e.g., life counseling)
Genetic (including gene transfer, stem cell and recombinant DNA)
Dietary Supplement (e.g., vitamins or minerals)
Combination Product (e.g., drug and device used together)
Diagnostic Test (e.g., imaging or lab assay)
Other

Name of Field: Intervention Name(s)
Definition: Enter a short descriptive name for the intervention(s) studied in each arm.

NOTE: If a non-proprietary name is available, it must be used.

Name of Field: Other Intervention Name(s)
Definition: Enter all other current and former names for the product (e.g., brand names or abbreviated names).

Name of Field: Intervention Description
Definition: Include details to distinctly identify the intervention from others. For example, interventions involving drugs may include dosage form, dosage, frequency and duration.

*Any interventions that are added should be correctly cross-matched to the corresponding intervention arm(s).

Primary Outcome Measure is referring to the outcome measure(s) of greatest importance (as specified in the protocol), which usually include the one(s) used in power calculation. Clinical studies should have at least one primary outcome measure, but some many have several.

Secondary Outcome Measure is referring to the outcome measure(s) that are of lesser importance than the primary outcome measure(s), but is part of a pre-specified statistical analysis plan for evaluating the effects of the intervention(s). A clinical study can have more than one secondary outcome measure.

Other Pre-specified Outcome Measure is referring to any other measurements that will be used to evaluate the intervention(s) or for observational studies, that are a focus of the study.

Outcome Measure(s)

Name of Field

Title

Definition

Enter the name of the outcome measure(s).

TIPS:

Include a quantitative (not qualitative) measure. For example, instead of "successful treatment of the lesion," include a title such as, "total number of subjects with complete response," that includes a tangible numerical measure.
If there are several measures, enter each measure separately.
There is a limit of 254 characters so keep it short but descriptive.
Expand acronyms at first use.

Name of Field: Description
Definition: Describe the metric used to characterize the specific outcome measure; it is important to define WHAT is being measured and not WHY it is being measured.

If a scored questionnaire or survey is used, the description must include the name of the scoring scale, what it is measuring, how the tool is scored, the score range from minimum to maximum, and the significance of the upper and lower limits (i.e., does a lower or higher score indicate a better outcome?).

Name of Field

Time Frame

Definition

Enter the time point(s) at which the measurement is assessed for the specific metric used.

If a change is being measured, then this field should include more than one time point, and "Change of..." should be included in the Outcome Measure Title.
If values are collected over several time points during the study period, then "Up to XXX sec/min/days/months/years" can be used to identify the entire period during which data will be collected for the outcome measure.

Interventional Trials

Name of Field: Sex
Definition: Select the sex of the subjects who are eligible to participate in the trial.

NOTE: "Sex" is based on biological distinctions between male and female.

Name of Field: Gender Based
Definition: Indicate whether the trial is enrolling based on gender.
If applicable, and the trial is enrolling based on gender, include a brief description on the gender criteria under "Gender Eligibility Description".

NOTE: "Gender" is referring to a person's self-representation of identity (not biological sex).

Name of Field: Age Limits
Definition: Enter the minimum and maximum age of potential subjects who are eligible for the trial (should be consistent throughout the record and with the study protocol and Rascal).

Minimum/Maximum Age: Enter the numerical value, if any. Unit of Time: Select the correct unit. If no limit, select "N/A (no limit)".

Name of Field: Accepts Healthy Volunteers
Definition: Select Yes or No.

Will subjects who have a disease or condition, or related conditions or symptoms, be eligible to enroll and participate in the trial?

Name of Field

Eligibility Criteria

Definition

Provide a list of criteria for the selection of subjects.

TIPS:

If applicable, create a bulleted list and separate the Inclusion Criteria from the Exclusion Criteria.
Avoid using terms that are too scientific or technical; eligibility will ultimately need to be confirmed by the investigator and study team.
Expand all acronyms at first use.

Observational Studies

Name of Field: Study Population Description
Definition: Include a description of the population from which the groups or cohorts will be selected (e.g., residents of a town or community).

Name of Field

Sampling Method

Definition

Indicate the method used for the sampling approach and explain it in the Detailed Description.

Probability Sample: Random process to guarantee that each subject or population has a chance of selection (e.g., random sampling).
Non-Probability Sample: Any other sampling processes, such as invitation to volunteer.

Name of Field: Central Contact Person
Definition: Identify the person who can answer any questions from the public regarding enrollment at any location.

First Name
Middle Initial
Last Name
Degree
Phone number and extension if needed (required)
Email address (required)

Name of Field: Central Contact Backup
Definition: Identify the person to contact if the Central Contact is not available.

First Name
Middle Initial
Last Name
Degree
Phone number and extension if needed
Email address

Name of Field: Overall Study Officials
Definition: Identify the person(s) responsible for the overall scientific leadership of the protocol. At minimum, the Principal Investigator (PI) should be added.

First Name
Middle Initial
Last Name
Degree
Organizational Affiliation
Official's Role (select from Study Chair, Study Director or Study Principal Investigator)

Name of Field: Locations
Definition: List each participating facility (i.e., study site) with the following information:

Facility Name (i.e., name of institution or organization)
City, State/Province
Zip/Postal Code
Country
Site Recruitment Status
Facility Contact
Facility Contact Backup
Investigator(s)

NOTE: Each facility must be listed separately and the recruitment status for that facility should be current. If at least one study site is "recruiting", then the Overall Study Status must indicate "recruiting" as well.

Name of Field: Plan to Share IPD
Definition: Indicate whether there is a plan to make individual participant data (IPD) available to other researchers. Sharing typically occurs after the end of the study.

If unsure select "Undecided" and change it once a determination of sharing has been made.

Name of Field

Plan Description

Definition

If there is a plan to share IPD, briefly describe what specific IPD data sets are to be shared.

You will need to identify:

IPD Sharing Supporting Information Type: choose from Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR) or Analytic Code.
IPD Sharing Time Frame: Indicate when the information will become available and for how long.
IPD Sharing Access Criteria: Define the criteria by which the IPD will be shared and by what mechanism. Information about who will review requests and the criteria can also be provided.
IPD Sharing URL: Provide the web address, if any, used to find additional information about the plan to share IPD.

If there are no plans to share IPD, use this field to provide an explanation as to why IPD will not be shared or why it is not yet decided.

For NIH-funded research, investigators should consider the new NIH Data Management and Sharing (DMS) Policy, which is effective January 25, 2023. The policy applies to all NIH-supported research that results in the generation of scientific data, regardless of funding mechanism.

Name of Field: Citations
Definition: Complete this field if there are any citations to publications that are related to the background information and/or results.

PubMed Identifier: Provide the PMID for the citation in MEDLINE.
Citation: Enter a bibliographic reference in NLM's MEDLINE format.
Results Reference: Indicate if the reference provides reports on results from this clinical study.

Name of Field: Links
Definition: Complete this field if there are any websites that are directly relevant to the protocol. Links to educational, research, government, and other non-profit web pages are acceptable; refrain from linking sites that advertise or sell commercial products or services.

URL: Provide the complete web address.
Description: Provide a title or brief description of the linked page (character limit of 254 characters).

Name of Field: Available IPD and Supporting Information
Definition: Complete this field with information on IPD sets and supporting information that are being shared for the study.

Available IPD/Information Type: Select the correct type.
Available IPD/Information URL: Provide the web address used to request or access the data set or supporting information.
Available IPD/Information Identifier: Provide the unique identifier used by a data repository for the data set or supporting information.
Available IPD/Information Comments: Provide additional information, including the name of the data repository or other location, where the data set or supporting information is available. Information about the data set and/or instructions for obtaining access can also be added.

ClinicalTrials.gov Definitions

Study Identification

Study Status

Sponsor/Collaborators

Oversight

Study Description

Conditions

Study Design

Interventional

Observational

Arms and Interventions

Arms (Interventional)

Groups/Cohorts (Observational)

Intervention(s)

Outcome Measures

Outcome Measure(s)

Eligibility

Interventional Trials

Observational Studies

Contacts/Locations

IPD Sharing Statment

References

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