Name of person completing this form
* must provide value
Email of person completing this form
* must provide value
GCO
STUDY
Study ID number (GCO or STUDY #)
* must provide value
Are results required to be posted for this study?
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
US NIH Grant/Contract Award Number Other Grant/Funding Number Registry Identifier EudraCT Number Other Identifier
Grantor or Funder/Registry Name/Issuing Organization
Brief Title
* must provide value
Official Title
* must provide value
Today M-D-Y
Overall Recruitment Status
* must provide value
Not yet recruiting Recruiting Active, not recruiting Enrolling by invitation Completed Suspended Terminated Withdrawn
Overall Recruitment Status Definitions
Not yet recruiting : Participants are not yet being recruited
Recruiting : Participants are currently being recruited, whether or not any participants have yet been enrolled
Enrolling by invitation : Participants are being (or will be) selected from a predetermined population
Active, not recruiting : Study is continuing, meaning participants are receiving an intervention or being examined, but new participants are not currently being recruited or enrolled
Completed : The study has concluded normally; participants are no longer receiving an intervention or being examined (that is, last participant's last visit has occurred)
Suspended : Study halted prematurely but potentially will resume
Terminated : Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Withdrawn : Study halted prematurely, prior to enrollment of first participant
Date of 1st Enrollment
* must provide value
Today M-D-Y
Date of 1st Enrollment Type
Actual Anticipated
Primary Completion Date
* must provide value
Today M-D-Y
Primary Completion Date Type
Actual Anticipated
Study Completion Date
* must provide value
Today M-D-Y
Study Completion Date Type
Actual Anticipated
Responsible Party
(Select Sponsor-Investigator if this study has an IND/IDE)
* must provide value
Principal Investigator Sponsor-Investigator
Investigator Name
* must provide value
Investigator Email
* must provide value
Investigator Official Title
Agencies & Organizations - NOT INDIVIDUALS
Agencies & Organizations - NOT INDIVIDUALS
Agencies & Organizations - NOT INDIVIDUALS
Agencies & Organizations - NOT INDIVIDUALS
FDA Regulated Intervention
Yes
No
Section 801 Clinical Trial
Yes
No
US Food and Drug Administration IND or IDE Study
if IND or IDE study, must answer the applicable related fields below.
* must provide value
Yes
No
CDER CBER CDRH
Availability of Expanded Access
Yes
No
Expanded Access Record NCT Number*Required if there is availabilty of Expanded Access
Studies a US FDA-regulated Drug Product
* must provide value
Yes
No
Studies a US FDA-regulated Device Product
* must provide value
Yes
No
Device Product Not Approved or Cleared by US FDA
* must provide value
Yes
No
Post Prior to US FDA Approval or Clearance
* must provide value
Yes
No
Pediatric Postmarket Surveillance of a Device Product
* must provide value
Yes
No
Yes
No
Data Monitoring Committee
* must provide value
Yes
No
Human Subjects Protection Review Board Status
* must provide value
Request not yet submitted Submitted, pending Submitted, approved Exempt Submitted, denied Submission not required
Board Approval Number
* must provide value
Write Pending if IRB approval is pending.
Board Name
* must provide value
Program for the Protection of Human Subjects BRANY Other
Board Affiliation
* must provide value
Icahn School of Medicine at Mount Sinai Biomedical Research Alliance of NY Other
View equation
Plan to Share IPD
* must provide value
Yes
No
Reason for not sharing IPD
* must provide value
IPD Description
* must provide value
All of the individual participant data collected during the trial, after deidentification.
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing - Supporting Information (Check all types of supporting information that will be shared.)
* must provide value
IPD Time Frame
* must provide value
Immediately following publication. No end date.
Beginning 3 months and ending 5 years following article publication.
Beginning 9 months and ending 36 months following article publication.
Specify Other Time Frame
With Whom?
* must provide value
Anyone who wishes to access the data.
Researchers who provide a methodologically sound proposal.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
For what type of analysis?
* must provide value
Any purpose.
To achieve aims in the approved proposal.
For individual participant data meta-analysis.
By what mechanism will data be made available?
* must provide value
Data are available indefinitely at (Link to be included in the URL field below).
Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included in the URL field below).
Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link to be included in the URL field below).
Specify Other Mechanism
Individual Participant Data Set Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report Analytic Code Other
Individual Participant Data Set Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report Analytic Code Other
Individual Participant Data Set Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report Analytic Code Other
Individual Participant Data Set Study Protocol Statistical Analysis Plan Informed Consent Form Clinical Study Report Analytic Code Other
Brief Summary
* must provide value
Detailed Description (please do not include information that is entered elsewhere on this registration)
* For Patient Registries
Also describe the applicable registry procedures and other quality factors (for example, third party certification, on-site audit). In particular, summarize any procedures implemented as part of the patient registry, including, but not limited to the following:
Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems). Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results. Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan Condition
* must provide value
Study Type
* must provide value
Interventional Observational Expanded Access
Primary Purpose
* must provide value
Treatment Prevention Diagnostic Basic Science Supportive Care Screening Health Services Research Device Feasibility Other
Study Phase
* must provide value
N/A Early Phase 1 Phase 1 Phase 1/Phase 2 Phase 2 Phase 2/Phase 3 Phase 3 Phase 4
Interventional Model
* must provide value
Single Group Assignment Parallel Assignment Crossover Assignment Factorial Assignment Sequential Assignment
Number of Arms
* must provide value
1 2 3 4 5 6
Masking (Check all Roles that are masked or check None)
* must provide value
Allocation
(choose N/A if one arm study)
* must provide value
Randomized Non-randomized N/A
Observational Study Model
Cohort Case-Control Case-Only Case-Crossover Ecologic or Community Family-Based Other
Time Perspective
* must provide value
Retrospective Prospective Cross-Sectional Other
Biospecimen Retention
* must provide value
None Retained Samples With DNA Samples Without DNA
Number of Groups/Cohorts
* must provide value
1 2 3 4 5 6
Patient Registry
* must provide value
Yes
No
Target Follow-up Duration
* must provide value
Target Duration Units
* must provide value
Years Months Weeks Days
Expanded Access Type
* must provide value
Expanded Access Status
* must provide value
Available No longer available Temporarily not available Approved for marketing
Enrollment - Number of Subjects
* must provide value
Enrollment Type
* must provide value
Actual Anticipated
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Arm Name
* must provide value
Arm Type
* must provide value
Experimental Active Comparator Placebo Comparator Sham Comparator No intervention Other
Arm Description
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
Intervention Type
* must provide value
Drug Device Biological/Vaccine Procedure/Surgery Radiation Behavioral Genetic Dietary Supplement Other
Intervention Name
* must provide value
Intervention Description
* must provide value
Select Arms
* must provide value
PRIMARY OUTCOME MEASURE
Title
(e.g. Data variable, questionnaire name)
* must provide value
Primary Outcome Measure Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
* must provide value
Primary Outcome Measure Time Frame
Time Frames should be specific.
Example: "end of study" is NOT acceptable. Instead, "end of study, at 6 months" is acceptable.
Example:" "several times for duration of study" is NOT acceptable. Instead, "at week 2 and week 4" is acceptable.
* must provide value
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Time Frame
Time Frames should be specific.
Example: "end of study" is NOT acceptable. Instead, "end of study, at 6 months" is acceptable.
Example:" "several times for duration of study" is NOT acceptable. Instead, "at week 2 and week 4" is acceptable.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Title
(e.g. Data variable, questionnaire name)
Description
For questionnaires or survey instruments, please include the min and max scale and what a higher score indicates in description.
Gender
* must provide value
All Female Male
Gender Based
Indicate whether participant eligibility is based on gender, ie, a person's self-representation of gender identity
* must provide value
Yes
No
Gender Eligibility Description
Minimum Age
(N/A for no limit)
* must provide value
Minimum Age Unit
* must provide value
Years Months Weeks Days Hours Minutes N/A
Maximum Age
(for no limit put in 99 and select N/A below)
* must provide value
Maximum Age Unit
(N/A for no limit)
* must provide value
Years Months Weeks Days Hours Minutes N/A
Accept Healthy Volunteers
(i.e. participants that do not have the condition of your research)
* must provide value
Yes
No
Eligibility Criteria
* must provide value
Study Population
* must provide value
Sampling Method
* must provide value
Probability Sample Non-Probability Sample
First Name
* must provide value
Last Name
* must provide value
Phone
* must provide value
Email
* must provide value
First Name
* must provide value
Last Name
* must provide value
Affiliation
* must provide value
Study Chair Study Director Study Principal Investigator
Study Chair Study Director Study Principal Investigator
Study Chair Study Director Study Principal Investigator
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
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