Registry Description

Definitions for the following fields

Registry Title

Definition

The title of the patient registry intended for the lay public.

Example

A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma

Registry Version

Definition

Used to identify the registry version. Assists in clarifying updates compared to previous versions.

Example

Version A, Version B, etc.

Last Updated On

Definition

A system-generated field showing the date of the most recent update (if applicable) to the original Registry Profile.

First Received On

Definition

A system-generated field showing the date of initial registration within the RoPR System.

Brief Description

Definition

Short description of the protocol intended for the lay public. Includes a brief statement of the study hypothesis.

Note:

After the ClinicalTrials.gov record has been released, the RoPR system will populate Brief Description with the value on ClinicalTrials.gov for consistency between the two systems.

Example

Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician.

Long Description

Definition

Extended description of the protocol, including more technical information.

Note:

After the ClinicalTrials.gov record has been released, the RoPR system will populate Long Description with the value on ClinicalTrials.gov for consistency between the two systems.

Example

In the United States, the prevalence of open-angle glaucoma for all adults 40 years old and older is estimated to be 1.86%. Open-angle glaucoma affects an estimated 2.22 million people, and that will rise to 3.3 million in 2020 as the population ages in the United States. Worldwide, it is estimated that 66.8 million people have glaucoma. Glaucoma of all types is one of the leading causes of legal blindness in the country. The study is a prospective, observational cohort study and will not provide or recommend any treatment. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice.

Registry Geography

Definition

Displays the geographical scope of the registry.

  • Single Institution/Practice: A registry taking place at an individual hospital/practice.
  • State: A registry based at multiple locations in a single state.
  • Regional:A registry based within a specific geographical area such as multiple states (e.g.; New England, Pacific Northwest).
  • National: A registry taking place within a single country.
  • Global: A registry with sites in multiple countries.

Registry Location

Definition

Allows further clarification for the Registry Geography.

Example

United States, Canada, the United Kingdom, and Germany.

RoPR ID

Definition

Unique Registry of Patient Registries profile identifier.

NCT ID

Definition

The ClinicalTrials.gov Identifier. The NCT ID is a hyperlink which will open the posting on ClinicalTrials.gov. The ClinicalTrials.gov record contains additional data about the registry, including start and end dates, eligibility criteria and recruitment status.

Note:

After the ClinicalTrials.gov record has been released, the RoPR system will populate NCT ID with the value on ClinicalTrials.gov for consistency between the two systems.

RoPR Record Permanent Link

Definition

A hyperlink which opens a version of the Registry Profile which can be bookmarked or shared with others.

History of Changes

Definition

A hyperlink which opens a comparative view of changes made to the Registry Profile.

Registry Classification And Purpose

Definitions for the following fields

Registry Classification

Definition

A high-level description of which disease or specific therapeutic area that the registry covers. Multiple choices can be indicated.

  • Disease/Disorder/Condition
  • Pregnancy
  • Product, Biologic
  • Product, Device
  • Product, Drug
  • Service, Encounter (e.g.: office or clinic visit)
  • Service, Hospitalization
  • Service, Procedure
  • Transplant
  • Tumor
  • Vaccine
  • Other
Note:

Some options (Pregnancy, Transplant, Tumor, or Vaccine) allow for greater detail than other selections. These options reflect common types of patient registries.


Registry Classification Other

Definition

A free text field to specify the "Other" option in Registry.

Registry Purpose

Definition

A high-level description for why the registry collects information. Multiple choices can be indicated.

  • Clinical Practice Assessment
  • Effectiveness
  • Natural History of Disease
  • Payment/Certification
  • Post Marketing Commitment
  • Public Health Surveillance
  • Quality Improvement
  • Safety or Harm
  • Other
Registry Purpose Other

Definition

A free text field to specify the "Other" option in Registry Purpose.

Contacts And Conditions of Access

Definitions for the following fields

Interested In Being Contacted

Definition

Displays if the registry holder is interested in being contacted.

Reasons For Being Contacted

Definition

Shows the reasons for why the registry holder wants to be contacted. Multiple choices can be indicated.

  • Collaboration (e.g.; shared research efforts based on data available in the registry)
  • Data Access
  • More Information
  • Participation - Investigator (e.g.; seeking new physicians, researchers, medical providers or sites to take part in collecting data for the registry)
  • Participation - Participant (e.g.; seeking people with medical conditions or patients to take part in the registry)
  • Other
Reasons for Contact Other

Definition

A free text field to specify the "Other" option in Reasons For Being Contacted.

Organization

Definition

Name of primary organization responsible for the registry.

Contact

Definition

The name, and optionally title, of the primary contact.

E-mail

Definition

The E-mail address of the primary contact.

Note:

Either E-mail or Phone is required if "Interested In Being Contacted" is set to Yes.

Phone

Definition

The phone number, including area code and extension (if available), of the primary contact.

Note:

Either E-mail or Phone is required if "Interested In Being Contacted" is set to Yes.

Link to Organization or Registry Site

Definition

The Web site address of the primary contact organization or the registry's Web site. Clicking the link will open a new browser window.

Link to Conditions of Access

Definition

A link to an external Web site, describing the conditions of access to the registry data. Clicking the link will open a new browser window.

Progress Report

Definitions for the following fields

Has Progress Report

Definition

Indicates if a Progress Report, or updates for the registry is available.

Date of Progress Report

Definition

A system-generated date showing when the Progress Report was first entered or updated.

Progress Report Title

Definition

A title for the Progress Report.

Example

2010-2011 Annual Report.

Progress Report Summary

Definition

A short description for the Progress Report.

Example

Annual Data Report for 2011-2012, with details for Demographics, Mortality Rates, and Patient-Reported Outcomes. Data collection for the report spans July 2011 through June 2012.

Number of Participants in Registry

Definition

Displays the number of patients enrolled in the registry at the time of the Progress Report. This includes whether the number is actual, estimated or not available at the time of the Progress Report.

Length of Follow-Up

Definition

Indicates the length of follow-up, in years at the time of the Progress Report. This includes whether the Length of Follow-up is actual, estimated or not available.

Link to Progress Report

Definition

A link to the Progress Report, if posted on an external Web site. Clicking the link will open a new browser window.

Related Information

Definitions for the following fields

Link

Definition

The link to the external Web site. Clicking the link will open a new browser window.

Link Description

Definition

A display of a short description of the link.

Outcome Measures and Common Data Elements

Definitions for the following fields

Condition or Service Focus of Registry

Definition

The primary disease, condition or service of the registry. These options use National Library of Medicine’s Medical Subject Headings (MeSH) which is widely used as a way to organize medical terminology.

Multiple choices can be indicated.

  • Bacterial and Fungal Diseases: Infections caused by bacteria and fungi, general, specified, or unspecified. MeSH Code C01.
  • Behaviors and Mental Disorders: Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function OR the observable response made to a situation and the unconscious processes underlying it. MeSH Codes F03 or F01.
  • Blood and Lymph Conditions: Hematologic diseases and diseases of the lymphatic system collectively. Hemic diseases include disorders involving the formed elements (e.g., erythrocyte aggregation, intravascular) and chemical components (e.g., blood protein disorders); lymphatic diseases include disorders relating to lymph, lymph nodes, and lymphocytes. MeSH Code C15.
  • Cancers and Other Neoplasms: New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. MeSH Code C04.
  • Digestive System Diseases: Diseases in any part of the gastrointestinal tract or the accessory organs (liver; biliary tract; pancreas). MeSH Code C06.
  • Diseases or Abnormalities at or before Birth: Diseases existing at birth and often before birth, or that develop during the first month of life (infant, newborn, diseases), regardless of causation. Of these diseases, those characterized by structural deformities are termed congenital abnormalities. MeSH Code C16.
  • Ear, Nose, and Throat Diseases: Pathological processes of the ear, the nose, and the throat, also known as the ENT diseases. MeSH Code C09.
  • Eye Diseases: Diseases affecting the eye. MeSH Code C11.
  • Gland and Hormone Related Diseases: Pathological processes of the endocrine glands, and diseases resulting from abnormal level of available hormones.
  • Heart and Blood Diseases: Pathological conditions involving the cardiovascular system including the heart; the blood vessels; or the pericardium. MeSH Code C14.
  • Immune System Diseases: Disorders caused by abnormal or absent immunologic mechanisms, whether humoral, cell-mediated, or both. MeSH Code C20.
  • Mouth and Tooth Diseases: General or unspecified diseases of the stomatognathic system, comprising the mouth, teeth, jaws, and pharynx. MeSH Code C07.
  • Muscle, Bone, and Cartilage Diseases: Diseases of the muscles and their associated ligaments and other connective tissue and of the bones and cartilage viewed collectively. MeSH Code C05.
  • Nervous System Diseases: Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle. MeSH Code C10.
  • Nutritional and Metabolic Diseases: A collective term for nutritional disorders resulting from poor absorption or nutritional imbalance, and metabolic disorders resulting from defects in biosynthesis (anabolism) or breakdown (catabolism) of endogenous substances. MeSH Code C18.
  • Occupational Diseases: Diseases caused by factors involved in one's employment OR Disorders caused by external forces rather than by physiologic dysfunction or by pathogens. MeSH Codes C21 or C24.
  • Parasitic Diseases: Infections or infestations with parasitic organisms. They are often contracted through contact with an intermediate vector, but may occur as the result of direct exposure. MeSH Code C03.
  • Respiratory Tract (Lung and Bronchial) Diseases: Respiratory Tract (Lung and Bronchial) Diseases. MeSH Code C08.
  • Skin and Connective Tissue Diseases: A collective term for diseases of the skin and its appendages and of connective tissue. MeSH Code C17.
  • Substance Related Disorders: Disorders related to substance abuse, the side effects of a medication, or toxin exposure. MeSH Code C25.
  • Symptoms and General Pathology: Abnormal anatomical or physiological conditions and objective or subjective manifestations of disease, not classified as disease or syndrome. MeSH Code C23.
  • Urinary Tract, Sexual Organs, and Pregnancy Conditions: Pathological processes of the urinary tract, the reproductive system, and disorders related to pregnancy. MeSH Codes C12 or C13.
  • Viral Diseases: A general term for diseases produced by viruses. MeSH Code C02.
  • Wounds and Injuries: Damage inflicted on the body as the direct or indirect result of an external force, with or without disruption of structural continuity. MeSH Code C26.
  • Other Condition: Any other condition not otherwise reflected in these selections.
Condition Other

Definition

A field for the "Other" option in Condition or Service Focus of Registry.

Category

Definition

The data element standards, scales, instruments, and measures utilized by the registry. Multiple choices can be indicated.

  • Clinical Assessments: Indicate if pre-defined clinical assessments are collected (e.g., breast cancer risk assessment tool, CPT codes).
  • Demographics: Indicate if patient demographic information is collected (e.g., race, gender, ethnicity, age).
  • Devices: Indicate if medical devices are collected (e.g., Class I, II, or III (device class) or hernia mesh (specific device)).
  • Diagnoses: Indicate if patient diagnoses are collected (e.g., pneumonia, congestive heart failure).
  • Disease Response: Indicate if disease response is collected (e.g., recurrence, progression).
  • Events of Interest: Indicate if events of interest are (e.g., adverse events, exacerbations, or medical events of special interest).
  • Genetic Information: Indicate if genetic information is collected (e.g., Participants genetic information, the genetics of the disease or pathogen).
  • Medications: Indicate if medications are collected (e.g., Rituximab (specific), disease-modifying anti-rheumatic (class)).
  • Patient Reported Outcomes: Indicate if Patient-Reported Outcomes are collected (e.g., PROMIS domains, SF-36).
  • Procedures: Indicate if medical procedures are collected (e.g., knee arthroplasty; CABG).
  • Risk Factors: Indicate if risk factors are collected (e.g., high blood pressure).
  • Staging Systems: Indicate if staging systems are collected (e.g., cancer stage).
  • Survival Outcomes: Indicate if survival outcomes are collected (e.g., mortality, disease-free survival).
  • Treatments: Indicate if treatments, not otherwise covered by Devices, Procedures or Medication, are collected (e.g., cognitive behavioral therapy).
  • Vitals: Indicate if patient vital statistics are collected (e.g., blood pressure; weight)
  • Other Category: Any other category not otherwise reflected in these selections.
Category Other

Definition

A field for the "Other" option in Category.