How to Read a Study Record

Learn how to read and understand a study record on BMU CTR.

Overview

The study record includes these main parts:

• Study introduction: At the top of the study record, this area provides the title of the study, administrative information about the study, and whether or not the study is looking for participants.
• Study sections: The rest of the record is organized into sections by the type of information and provides details about how the study works and the people involved.
• Summary results: This section provides the results of the study, if they have been posted.
• History of changes: This section lists every published version of the study record.

You can scroll through the study record to see each section in order.

Helpful features

The Study introduction area

In this area you’ll find information that applies to the entire study record.

• Study status – whether the study is currently looking for or not looking for participants
• Brief title of the study - a short title that describes what the study is about
• BMU CTR ID (BDCTR ID) - the ID number assigned to this study when it was first published on BMU CTR, in the format BDCTR-YYYY-NNNNNN
• Study sponsor - the organization or person who has control over the study
• Last Update Posted - the date the last changes to the study record were posted on the BMU CTR website

The study sections

These sections contain information about the people involved in the study, how it will be conducted, and information about participation.

The possible sections are:

• Description
• Conditions
• Study design
• Arms & interventions
• Outcome measures
• Eligibility
• Sponsor & contacts
• Locations
• Dates
• Ethics

Note that the study records for each type of study will have different types of information available.

Description

This section tells you what the study is about. The information you might find includes:

• Brief Summary and Detailed Description - the purpose of the study
• Official Title - the title given to the study by the researchers, often written in scientific language
• Acronym - the abbreviated name of the study, if it has one
• Other Study ID Numbers - other identifying numbers for the study, such as the sponsor's ID or an ID from another registry

Conditions

The focus of the study, usually a disease, illness, or condition, but may also be another health-related issue.

Study design

This section describes how the study is set up and run. Each type of study has slightly different information and the lists below do not include all the possible types of information you might find here.

• Study Type
  • Interventional (also called clinical trials) – studies in which participants are assigned to receive an intervention so that researchers can study the effects
  • Observational (including patient registries) – studies in which participants are not assigned to receive an intervention and are observed over time for health-related outcomes
  • Expanded Access – studies that allow patients with serious conditions to receive a drug or treatment outside of a clinical trial
• Phase - the stage of the study, for clinical trials of drugs
• Enrollment - the number of participants who joined a study or the number researchers hope will join the study

• Interventional study (clinical trial):
  • Primary Purpose - what is being studied, such as a test (diagnostic) or a treatment
  • Allocation - how participants are assigned to a treatment or control
  • Interventional Model and Interventional Model Description - the way the researchers assign interventions to participants in a clinical study
  • Masking - a procedure used in a study to keep participants unaware of what group they are in and what treatment they are receiving

• Observational study:
  • Observational Model - the way participants are identified and followed during an observational study
  • Time Perspective - whether the researchers will collect data during the study or will use data that has already been collected
  • Biospecimen Retention and Biospecimen Description - the type of sample that will be collected and stored from study participants, such as a blood sample or skin sample (not all studies will have this information)

Arms & interventions

This section shows the groups (arms) of participants in the study and what intervention each arm of the study will receive. The intervention is the treatment, device, or procedure that’s being studied. For an observational study, this section describes the characteristics of the group or groups in the study.

Outcome measures

This section often has a table format to explain:

• Primary Outcome Measures - the most important measures to learn the effects of the drug, device, or intervention, including how and when researchers will measure it
• Secondary Outcome Measures - these measures are still of interest, but less important than the primary measures
• Other Pre-specified Outcome Measures - any other measures that are part of the study

Eligibility

Also known as Participation Criteria, this section gives details about the types of participants that the study researchers need for the study.

Most records will show the eligibility criteria as:

• Inclusion Criteria - the characteristics of people who can join the study
• Exclusion Criteria - the characteristics of people who cannot join the study

You will also find:

• Ages Eligible for Study - the ages of people who can join the study
• Sexes Eligible for Study - the biological sex of people who can join the study
• Accepts Healthy Volunteers - tells if the study accepts participants who are healthy

Sponsor & contacts

This section names the sponsor and the Responsible Party (the person or organization responsible for entering the study information), and provides information on who to contact with questions about participating in the study. If available, the study contact information can be found under the Study Contact or under a specific location, listed as Contact.

Contacts

• Study Contact or Location Contact - the name and contact information for someone who can answer questions about joining the study, the types of participants the study is looking for, and what happens during the study
• Study Contact or Location Contact backup - the name and contact information for someone you can reach if you can’t reach the main Study Contact or the location contact (not always shown)

Important points about study contact information:

• Information for contacting a study is only available for a study that is open for participants.
  • For an Interventional or Observational study, contact information is listed for a study that is “Not yet recruiting” or “Recruiting." Note that a study that is "Not yet recruiting" may not have contact information.
  • For an Expanded Access study, contact information is listed if the Study Status is "Available."
• No contact information is listed for a study with a Study Status that is “Active, not recruiting,” “Completed,” “Terminated,” “Enrolling by invitation,” “Suspended,” or “Withdrawn."
• For studies that have an “Unknown” Study Status, contact information may or may not be shown, depending on the last known status of the study. If a Study Contact is listed, the contact information may not be up to date.

The names of other people and organizations carrying out the study, such as collaborators and investigators, may also be listed.

Locations

This section lists the locations where the study is taking place, also called clinical sites. A location name may be listed but an address will not be.

Dates

This section shows the study start date and completion dates; some of these may be estimated dates. It also shows administrative dates for the study, such as when the study was first posted and when the record was last updated on BMU CTR.

Ethics

This section shows the ethics review of the study: whether it was approved by an ethics committee or Institutional Review Board (IRB), the name of the committee, and the approval number. Ethics approval is given by the ethics committee, not by BMU CTR.

It may also show the Plan for Individual Participant Data (IPD) - a description of whether individual participant data will be shared, when it will be shared, and how it will be protected.

The Summary results section

This section contains the results of the study, if available. To learn more about the information found in the Summary results section, see How to Read Study Results.

The History of changes section

This section shows the history of changes to the study record. You can use this section to see every published version of the study record and the changes made to the study record over time. This section is most often used by data researchers.