Foundation Dataset Definitions & Glossary
CRUNCHBASE: the result of an integration with Crunchbase, this dataset captures business information for nearly 2 million private and public companies globally including contacts, funding rounds, investments, acquisitions, and parent-child company relationships.
Organization: Criteria pertaining to a public or private company.
Company Name: The name of a specific company or organization, public or private.
Employee Count: The number of individuals currently employed by the company.
Status: Indicates whether the company is active or no longer operating.
- Operating: The company is active.
- Closed: The company is no longer active.
- Acquired: The company was acquired by another entity and no longer operates under its original name.
Founded On: The date the company legally came into existence.
Investor Type: A high-level classification of a company’s role as an investor in other companies.
Funding Total (USD): The amount of funding a company has received to date in US dollars.
Last Funding On: The date on which the company received the latest venture funding.
Last Funding Type: High-level classification of the company’s latest funding round.
Acquired by: The name of the company’s acquirer, if applicable.
US State: Geographic state in which the company’s venture-related activities take place.
Country: Country in which the company’s venture-related activities take place.
Region: Region in which the company’s venture-related activities take place.
Sub-Region: Sub-region in which the company’s venture-related activities take place.
Categories: Venture-specific structured descriptors of the company’s industry.
Category Groups: Hierarchical grouping of venture-specific industry descriptors.
Name: Name of the individual employed by the company.
Job Title: Referring to the individual’s position or title within a company.
Job Type: Referring to the level of leadership or the role the individual plays within a company.
Funding Rounds: Funding rounds in which a company has participated as a recipient of capital.
Investor Name: The name of the company or entity who has provided funding to another company.
Investment Type: High-level classification of one of the company’s funding rounds.
Raised amount (USD): The amount of money raised through the process of seeking and gathering voluntary financial contributions by engaging individuals, businesses, charitable foundations, or governmental agencies.
Announced on: The date on which the funding round was announced.
Investments: Investments in which a company has participated as an investor of capital.
Target Company Name: The name of the company or entity who was the recipient of capital.
Investment Type: High-level classification of funding rounds supplied by the investing company.
Lead Investor: The individual or an organization who lead the funding round and may also act on behalf of the other investors.
Raised amount (USD): The amount of money raised through the process of seeking and gathering voluntary financial contributions by engaging individuals, businesses, charitable foundations, or governmental agencies.
Announced on: The date on which the investment was announced.
Categories of Target Company: Venture-specific industry descriptors relating to the company who is/was the recipient of capital.
Category Groups of Target Company: Hierarchical grouping of venture-specific industry descriptors of the company who is/was the recipient of capital.
Acquisitions: A transaction in which the given company acts as an acquirer of another company.
Acquiree Name: The name of the company who acts as an acquirer of another company.
Acquisition Type: Refers to the strategy or approach of the acquiree when
acquiring a new company; Leveraged Buy Out (LBO), Merge, Management Buyout, etc.
Acquisition Date: The date on which the acquirer obtains control of the acquiree.
Acquisition Price (USD): The price that was actually paid for an asset when it was first acquired.
PATENTS: dataset containing ~78 million patents from United States Patent and Trademark Office (USPTO), the European Patent Office (EPO), and World Intellectual Property Organization (WIPO). Coverage begins in the late 1700s.
Filing Status: Signifies whether or not the patent office has approved the application:
- Application: the application has been received but not yet approved.
- Grant: the patent application has been approved and legal rights have been granted by the patent office.
Languages: The language in which the patent was originally filed.
Patent Family: A collection of patents that are related to each other through priority claims.
Forward Citation Count: The number of times a patent family has been cited.
Family Size: The number of patents within the family.
CPC Symbol: The Cooperative Patent Classification (CPC) Symbol is an internationally recognized code developed by the European Patent Office (EPO) and United States Patent and Trademark Office (USPTO) for describing the patent’s subject matter.
Inventor Name: Name of the individual or entity responsible for creating the invention.
Inventor Country: The country in which the inventor is legally located.
Assignee Name: Name of the individual or entity that is the legal IP rights holder of the patent.
Assignee US State: The US State in which the assignee is legally located.
Assignee Country: The country in which the assignee is legally located.
Assignee Organization Type: The type of entity that is the legal IP rights holder or the type of entity that the individual legal IP rights holder is associated with; corporate (industry) or research institute (academic).
Assignee Portfolio Size: The number of patent families associated with the individual or entity.
Assignee Inventor Count: The number of individuals that are listed as inventors of technology described in the patent.
Applicant Name: The name of the individual or entity who filed the patent application.
Applicant Country: The country in which the applicant is legally located.
Applicant Organization Type: The type of entity that filed the patent application or the type of entity that the individual who filed the patent application is associated with; corporate (industry) or research institute (academic).
Patent Office: The authoritative body that confers exclusive IP rights in a particular jurisdiction.
Kind Code: A unique code used by the WIPO and USPTO that can help to distinguish the kind of patent document. You can find a list of WIPO ST.16 Kind Codes here and the USPTO Kind Codes here.
Filing Date: The date on which the patent application was filed.
Publication Date: The date on which the publication was produced by the patent office.
Priority Date: The date of the earliest filing in a family of patent applications.
Compound: (For related definitions, please see COMPOUNDS dataset below.)
Attorney Name: Name of the attorney or attorneys who served as a patent agent in the prosecution of a patent.
Examiner Name: The name of the employee or employees responsible for determining whether or not the patent can be granted to the applicant.
Department: The department in which the examiner belongs to often pertaining to scientific speciality or role in the patent adjudication.
CLINICAL TRIALS: dataset containing over 520,000 global clinical trials from ClinicalTrials.gov, EU Clinical Trials Register, Australia New Zealand Clinical Trials Registry, and more. Coverage dates back to the early 1900s, and is comprehensive as of the mid 1990s.
Eligibility Tags: Tags extracted from the unstructured ‘eligibility’ field in the underlying clinical trial record if available.
Track Code: Unique trial identifier assigned by the registry from which the trial record originated.
Data Source: The clinical trial registry from which the clinical trial was extracted.
Sponsor Name: Name of the entity that is responsible for managing and funding the clinical trial, but not necessarily the entity responsible for conducting it.
Organization Type: The type of entity that is responsible for managing and funding the clinical trial; university, research institute, or corporation.
Location Name: The name of the institution where the clinical trial was conducted.
US State: The state or states where the trial was physically conducted.
Country: The country or countries where the trial was physically conducted.
Study Type: Whether the trial is interventional, observational, expanded access, registrational, a meta-analysis, etc.
- Interventional: A type of trial where participants are assigned to groups that receive one or more treatment (or no intervention) so that researchers can evaluate the effects of the treatment via biomedical or health-related outcomes.
- Observational: A clinical study in which researchers observe participants or measure certain outcomes to determine health outcomes instead of assigning participants to a treatment or other intervention.
- Registrational: A registrational clinical trial refers to either a Phase III clinical trial or pivotal Phase II clinical trial conducted in furtherance of Regulatory Approvals.
- Expanded Access: A trial where an investigational new drug (IND) or biologic is used to treat a patient with a serious or life-threatening disease or condition and who does not meet the enrollment criteria for a clinical trial in progress or have alternative therapies available.
- Meta-analysis: examination of data from a number of independent studies of the same subject in order to determine overall trends.
Intervention Model: Describes the particular groups within an interventional study based on whether they received treatment, and the type of treatment they received if any.
- Crossover Assignment: Model where patients are randomly assigned to study arms where each arm consists of at least two treatments given consecutively. Also known as a randomized controlled trial.
- Diagnosis: A model intended to evaluate the accuracy of diagnostic procedures and/or tests.
- Educational, Counseling, Training: A model whereby educational tools or material is introduced to the trial.
- Factorial Assignment: A model in which groups of participants receive one of several combinations of therapies or interventions.
- Parallel Assignment: A model where patients are assigned to one of two groups where they are given different interventions or treatments for direct comparison.
- Prevention: A model aimed at preventing the occurrence of a disease or curing patients with a disease.
- Single Group Assignment: A model where only one therapy is available to all participants, ie. all patients receive the same therapy.
- Treatment: A model where the aim of the study is to treat patients suffering with a specific condition or disease.
Masking: A process referring to the participants or even the care givers in a study being blinded or not.
- Open: A study where both the study participants and researchers know which treatment the patient is receiving.
- Double-Blind: A type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the clinical trial is over.
- Single-Blind: A study in which only the researcher conducting the study knows which treatment or intervention the participant is receiving until the trial is over.
PI Name: The name of the principal investigator responsible for conducting the trial.
Outcomes: A clinical outcome is a measurable change in symptoms, overall health, ability to function, quality of life, or survival outcomes that result from giving care to patients.
Primary: The primary outcome is the variable that is the most relevant to answer the research question.
Secondary: Secondary outcomes are additional outcomes monitored to help interpret the results of the primary outcome.
Intervention Name: The name of the method or treatment administered to the patients in the trial.
Trial State: Indicates the clinical maturity or investigative phase of the study.
Phase: Refers to various parts of the clinical research process that answer specific questions about whether treatments or other interventions that are effective and safe.
- Phase I: Typically involves a new drug and is usually the first trial that involves people. Phase I studies are done to investigate the highest dose of the drug that can be given safely and without severe side effects.
- Phase II: Phase II trials are usually randomized, controlled studies evaluating the safety and efficacy of a drug for a particular condition and involve participants selected using narrow criteria, to allow close monitoring of a relatively homogenous patient population.
- Phase III: Phase III trials are intended to evaluate how the new medication works in comparison to existing medications for the same condition and usually involve a larger patient population.
- Phase IV: Typically Phase IV studies evaluate the side effects caused over time by a new treatment after it has been approved and is on the market, specifically intended to look at side effects that were not seen in earlier trials and may also study how well a new treatment works over a longer period of time.
Status: Whether the trial is active or not, and in what stage it is currently operating.
- Completed: Treatment is completed and the primary outcome or other outcomes have been assessed.
- Recruiting: The trial has started recruiting patients but hasn’t yet started treatment.
- Terminated: The trial was terminated due to unforeseen reasons (ie. poor enrollment, safety concerns, never initiated, lack of funding, etc.)
- Not yet recruiting: The study is planned but hasn’t started recruiting patients.
Eligibility Criteria: The requirements that must be met for an individual to participate in the clinical trial such as age, gender, overall health, whether they’ve had previous treatment, etc.
Eligible Gender: The gender of the patient required to participate in the trial. A trial may recruit only males, only females, or both.
Minimum Age: The minimum age in years the patient must be in order to participate in the trial.
Maximum Age: The maximum age in years the patient can be in order to participate in the trial.
Healthy Volunteers: Indicates whether the trial is recruiting healthy patients or patients that have already been diagnosed with a disease or condition.
Enrollment Count: The number of patients that have been recruited to participate in the study.
Enrollment Type: Refers to whether the enrollment count is estimated or if it is verified.
- Actual: The verified number of patients recruited to the study; often reported after trials have finished enrolling.
- Anticipated: The number of patients the sponsor aims to recruit for the study; often reported before enrollment is complete.
Start Date: The date on which the first patient was enrolled in the study.
Completion Date: The date on which the last participant in the study was examined or received an intervention to collect trial data for the primary outcome.
Duration (Years): The number of years that took place between the study start date and the study completion date.
Updated Date: The date on which the most recent update to the clinical trial record took place.
RESOLUTE RESEARCH NETWORK: dataset capturing nearly 250,000 prominent medical researchers from over 350 universities globally.
Full Name: First and last name of a particular researcher or expert.
Title: The title of the researcher or expert.
Affiliations: Entities that the researcher may be affiliated with currently or previously.
University: The name of the university the researcher is affiliated with.
Department Name: The name of the department within the university that the researcher is affiliated with.
COMPOUNDS: dataset containing chemical information for over 14 million compounds including chemical structure, molecular formula and weight, mass, etc.
Fingerprints: A molecular fingerprint encodes the structure of a molecule. It is a useful method to describe the structural similarity among the molecules.
Exact Match: In a chemical structure search, the search will only return a hit on an exact match if it is a complete structure, not a substructure.
Structural Similarity: The similarity of chemical elements, molecules or chemical compounds with respect to either structural or functional qualities.
Substructure: In a chemical structure search, the search results include any molecules containing the structure of interest as part of the complete structure.
Superstructure: In a compound search, the result includes molecules that comprise or make up the provided chemical structure query.
Molecular Weight: The mass of a molecule calculated as the sum of the mass of each constituent atom multiplied by the number of atoms of that element in the molecular formula.
Surface Area (A2) / PSA: PSA is the surface sum over all polar (positive/negative charged) atoms or molecules, primarily oxygen and nitrogen, also including their attached hydrogen atoms
XlogP3: Predicts the logP value of a query compound by using the known logP value of a reference compound as a starting point.
Complexity: The complexity rating of a compound is a rough estimate of how complicated the structure is, seen from the point of view of both the elements contained and the displayed structural features including symmetry.
Exact Mass: The exact mass of an isotopic species is obtained by summing the masses of the individual isotopes of the molecule.
Monoisotopic Mass: The sum of the accurate masses of the most abundant naturally occurring stable isotope of each atom in the molecule.
DRUGS: dataset capturing approved and marketed drugs globally. Coverage dates back to the 1980s.
Effective Time: Date referencing a particular version of the labeling document.
Brand Name: Brand or trade name of the drug product.
Generic Name: Generic name of the drug product.
Manufacturer Name: The manufacturer or company that makes the drug product corresponding to the labeler code segment of the NDC (National Drug Codes).
Pharm Class CS: Chemical structure classification of the drug product’s pharmacological class.
Pharm Class EPC: Established pharmacological class associated with an approved indication of an active generic drug that the FDA has determined to be scientifically valid and clinically meaningful.
Pharm Class PE: Physiological effect or pharmacodynamic effect of the drugs pharmacological class.
Pharm Class MoA: Mechanism of action of the drug’s established pharmacological class.
Product Type: Whether the drug is prescribed or if it can be obtained over-the-counter.
Route: The drug’s route of administration.
Substance Name: The name of the active ingredient(s) in the drug.
Sponsor Name: The company that submitted the application to the FDA requesting approval to market a drug product in the US.
Applicant: The firm holding legal responsibility for the new drug application.
Approval Date: The date the FDA approved the drug product.
Dosage Form: The form in which the drug is administered to the patient.
TE Code: (Therapeutic Equivalence Code) A coding system for therapeutic equivalence evaluations that allows users to determine whether the FDA has evaluated a particular approved drug as therapeutically equivalent to other pharmaceutical products. For a list of all TE Codes, visit https://medcraveonline.com/MOJBB/fdarsquos-orange-book-and-ab-ratings-of-pharmaceutical-drug-products-a-guide-to-community-pharmacist.html.
Reference Listed Drug: Whether or not the drug has been identified by the FDA as a reference drug, ie. the product upon which the applicant relies in seeking approval of its ANDA.
Reference Standard: Whether or not the FDA has selected the drug as a reference standard, ie. the applicant seeking approval of an ANDA must use the drug in an in vivo bioequivalence study.
Patent Number: Patent numbers submitted by the applicant holder for patents covered by the statutory provisions.
Patent Expiration Date: The date that the patent expires as submitted by the applicant holder, includes applicable extensions.
Drug Substance: Indicates whether or not the sponsor submitted the patent as claiming the drug substance.
Drug Product: Indicates whether or not the sponsor submitted the patent as claiming the drug product.
Patent Use Code: A code to designate a patent that covers the approved indication or use of a drug product.
Patent Delist Requested: Whether or not the sponsor has requested the patent be delisted.
Submission Date: The date on which the FDA receives patent information from a new drug application (NDA) holder.
Exclusivity Code: Code to designate patent exclusivity granted by the FDA to a particular drug product.
Exclusivity Date: The date that patent exclusivity expires.
GRANTS: dataset covering grants sourced from grants.gov, Horizon 2020/Horizon Europe?, NIH RePORTER, National Science Foundation, SBIR.gov, and Wellcome Trust.
Organization: The entity that is the recipient of the grant award.
Country: The country where the entity that is the recipient of the grant award is physically located.
US State: The US State where the entity that is the recipient of the grant award is physically located.
PI Name: The name of the Principal Investigator (PI) at the recipient organization who is responsible for coordinating research performed under the grant.
Award Amount: The grant award amount given in the original currency. This amount is not cumulative in the case of related grant groups.
Award Start Date: The start date of research activities performed under the terms of the grant award.
Award Close Date: The end date of research activities performed under the terms of the grant award.
Award Notice Date: The release date of the grant notice.
Contact Name: Name of the contact person for the grant at the recipient organization.
Branch: Armed services branch sponsoring the grant, if any.
Agency: Government agency sponsoring the grant, if any.
Solicitation Date: The date on which the agency or branch makes known its intentions to award a grant or cooperative agreement, usually as a result of competition for funds. May also be known as funding opportunity announcements, program announcements, notices of funding availability, etc.
Employee Count: The employee count of the grant recipient organization, if available.
SBA Phase: Refers to the US Small Business Administration’s environmental policies to perform environmental due diligence on SBA guaranteed loans.
- Phase I: An environmental study that aims to identify potential areas or chemicals of concern. It typically includes site and area reconnaissance, regulatory and historical records review, and interviews with key site personnel.
- Phase II: Study that occurs after the identification of possible or actual contamination during a Phase I ESA, utilizing site exploration, sampling in areas of concern, and laboratory analysis for chemicals of concern.
SBA Program: Indicates the type of grant program offered by the US Small Business Administration.
- SBIR: An SBIR (Small Business Innovation Research) Program encourages small businesses to further their R&D efforts and incentivizes them to commercialize and profit from their technologies. Helps small businesses compete on the same level as larger businesses.
- STTR: The STTR (Small Business Technology Transfer) Program helps a small business by expanding funding opportunities in innovation. The program is intended to help foster the innovation needed to address the latest scientific and technological challenges.
NIH Program Code: The NIH uses activity codes to differentiate the wide variety of research-related programs and activities that they support. You can find details about the specific codes on the NIH’s website here: https://grants.nih.gov/grants/funding/funding_program.htm.
DUNS Code: A unique code given by the Data Universal Numbering System (DUNS). All applicants for federal grants and cooperative agreements must have a DUNS number so that the government can identify related organizations that are receiving funding under grant and cooperative agreements.
Data Source: The agency or entity where the grant award originated from.
Opportunity Close Date: The deadline given by the grant-making agency designated for submission of a particular grant application.
Opportunity Record Type: Refers to the status of the funding opportunity.
- Synopsis: a funding opportunity that has been previously announced and the deadline for applications for new awards has passed
- Forecasted:the agency has invited or expects to invite applications for new awards and provides an actual or estimated deadline for application submissions.
Opportunity Category: Indicates the type of funding opportunity:
- Discretionary: The awardee is selected based on merit and eligibility.
- Mandatory: A type of grant that must be awarded to each eligible applicant based on the conditions given in the opportunity.
- Earmark: Earmark funds are congressionally directed spending requests or Community Project Funding requests. Federal funding is directed to support local projects that enhance community priorities, transportation, healthcare, education, job opportunities, etc.
- Continuation: An extension or renewal of existing program funding for one or more additional budget period(s). These grants are typically available to existing recipients of discretionary, multi-year projects.
Funding Instrument type: The trust agreement that states the terms under which the funding agency will accumulate, administer, and disburse funds.
- Grant: A grant is an award of funding in which the awarding agency strictly maintains an oversight and monitoring role in the research activities of the recipient organization.
- Cooperative Agreement: A cooperative agreement is different from a grant in that it typically involves substantial involvement from both the Federal agency or pass-through entity and the recipient organization of the grant award.
- Procurement Contract: Used by Federal agencies to acquire property, materials, or services to be used by the United States government.
Category of Funding Activity: The hierarchical categorization of NIH activity codes used to differentiate the wide variety of research-related programs and activities that they support. You can find details about the specific codes on the NIH’s website here: https://grants.nih.gov/grants/funding/funding_program.htm.
CFDA Number(s): A Catalog of Federal Domestic Assistance (CFDA) number is a five-digit number assigned in the awarding document to most grants and cooperative agreements funded by the Federal government.
Eligible Applicants: The legal requirements given by the Federal agency that the applicant must meet to be eligible for funding.
Cost Sharing or Matching Requirement: Indicates whether or not project costs will be paid using Federal funds.
NEWS: includes over 225 million global news events from the past 2 years focusing on science, technology, engineering, mathematics.
Published Date: The date on which the news article or announcement was published.
Languages: The language or languages of the underlying source data.
Source: Where the resulting news article or record was mined from.
Authors: The individual or individuals who wrote the news article, press release, or announcement.
Companies Mentioned: The companies mentioned or featured in a particular news article, press release, or announcement involved in the reported event.
Company Topics: Corporate topics and filings.
Country: The country where the news event in question took place or the country
of the companies mentioned.
US State: The US State where the news event in question took place or the US State of the companies mentioned.
Geography: The regions, provinces, cities or other locations where the news event in question took place or the location of the companies mentioned.
Government: News pertaining to a specific US Federal or State agency.
Industries: Indicates which industry impacts or pertains to the news piece .
NGOs: News pertaining to a specific think tank, association, or government agency.
Universities: News pertaining to a specific university or academic institution.
Research Providers: News pertaining to any person or organization that conducts research.
DRUG ADVERSE EVENTS: dataset capturing over 1.3 million adverse events for marketed drugs globally, including seriousness, actions taken, manufacturer names, administration route, etc.
Safety Report ID: An 8-digit number, also known as the case report number of case ID, that corresponds to a specific adverse event report.
Regulatory Authority Case Report Number: An identifier assigned by the Regulatory Authority in question in reference to a specific case or adverse event report.
Reporting Company: A self-assigned identifier for the company that provided the report.
Expedited: Indicates whether or not the report was expedited (processed within 15 days).
Transmission Date: The date that the record was created–can be earlier than the date received by the FDA.
Date Received by FDA: The date that the record was first received by the FDA, and reflects the earliest version of the report if multiple exist.
Report Type: Indicates the circumstances under which the report was generated.
Seriousness: Corresponds to the severity of the outcome caused by the reported event.
Event Country: The country in which the event occurred.
Patient Age Group: Describes the age group of the patient(s) who were affected by the event.
Patient Sex: The sex of the patient(s) affected by the event.
Drug Authorization Number: The drug authorization or application number (NDA or ANDA) if provided.
Lot Number: Drug product lot number if provided.
Application Number: The NDA, ANDA, or BLA number as provided by the drug labeler. If the drug is unapproved, the number will show as ‘Null’.
Nui: Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
Unique Ingredient Identifier: A non-proprietary, non-semantic, free, unique, unambiguous, alphanumeric identifier based on the drug’s molecular structure and/or descriptive information.
Active Ingredient: The active ingredient in the drug product. Can differ from other drug identifiers when provided.
Drug Administration Route: The way by which a drug is taken into the body.
Drug Taken Start Date: The date the patient began taking the drug.
Drug Taken End Date: The date the patient stopped taking the drug.
Drug Indication: The disease or disorder that the drug is treating.
Reaction Recurrence: Whether the reaction occurred after readministration of the drug.
Drug Recurrence Reaction: Indicates the type of reaction that occurred after readministration of the drug.
Medicinal Product: A non-systematic or normalized field that corresponds to the drug’s name, including the valid trade name (ex. ‘Advil’ or ‘Aleve’) or the generic name (ex. ibuprofen) of the product.
Brand Name: Brand or trade name of the drug product.
Generic Name: Generic name of the drug product.
Manufacturer Name: Name of the manufacturer or company that makes the drug product, corresponds to the labeler code segment of the NDC.
Pharm Class CS: Chemical structure classification of the drug product’s pharmacological class.
Pharm Class EPC: Established pharmacological class associated with an approved indication of an active generic drug that the FDA has determined to be scientifically valid and clinically meaningful.
Pharm Class PE: Physiological effect or pharmacodynamic effect of the drugs pharmacological class.
Pharm Class MoA: Mechanism of action of the drug’s established pharmacological class.
Product Type: Whether the drug is prescribed or if it can be obtained over-the-counter.
Substance Name: The name of the active ingredient(s) in the drug.
Qualification of Reporter: Category of the individual who submitted the report.
Country of Reporter: The country where the individual who submitted the report is located.
Reaction MedDRA term: MedDRA classification of the patient’s reaction. Terms are coded in British English.
Reaction Outcome: Outcome of the reaction at the time of the last observation.
MAUDE (Manufacturer and User Facility Device Experience): this dataset of over 13.6 million device reports results from an integration with MAUDE, a database that captures reports submitted to the FDA from manufacturers, importers, device user facilities, health care professionals, patients, consumers, etc.
MDR Report Key: A field that identifies unique reports in the Medical Device Reporting (MDR) system and is used to link Maude files together.
Report Number: The number used to identify the adverse event report–can consist of the Manufacturer Report Number or the Distributor Report Number depending on who reported the event.
Report Source: Describes whether the report originated from the manufacturer, the distributor, or user facility, or if it was voluntary (from healthcare professionals, patients, caregivers, and consumers.
Source Type: The source of the manufacturer-reported event.
Reporter Occupation: The occupation of the individual who originally reported the event.
Reporter is Health Professional: Indicates whether or not the individual who reported the event is a healthcare professional.
Type of Report: Indicates whether the report is an initial submission or if it is a follow-up to an existing report.
Event Type: Specifies the outcome associated with the adverse event.
Event Location: The setting in which the adverse event occurred.
Is This An Adverse Event Report?: Indicates whether or not the report includes an incident where the use of a device is suspected to have resulted in an adverse outcome in a patient.
Is this a Product Problem Report?: Indicates whether or not the report was about the quality, safety, or efficacy of a device.
Product Problem: Specifies the type of problem associated with a device as reported.
Report Sent to FDA: Whether the report was sent to the FDA by a distributor (user facility or importer). User facilities are required to submit reports to the FDA for any device-related deaths, and importers are required to submit reports for any device-related deaths or serious injuries.
Initial Report to FDA: Indicates whether or not the initial reporter also sent the report to the FDA.
Date of Event: Actual or best estimate of the date of the first onset of the adverse event.
Initial Report Date: Date that the initial reporter reported the event to the manufacturer, user facility, or importer.
Report Date: The date that the report was forwarded to the manufacturer and/or the FDA.
Date Report Sent to FDA: Date that the user facility or importer sent the report to the FDA if applicable.
Date FDA Received: The date on which the FDA received the report.
Date Reported to Manufacturer: The date on which the user facility or importer sent the report to the manufacturer.
Manufacturer Contact Name: The contact person at the manufacturer.
Manufacturer Contact State: The US State in which the contact person at the manufacturer is located.
Manufacturer Contact Region/Province: The region or province in which the contact person at the manufacturer is located.
Manufacturer Contact Country: The country in which the contact person at the manufacturer is located.
Manufacturer Name: The manufacturer of the device.
Manufacturer State: The US state in which the device manufacturer is located.
Manufacturer Region/Province: The region or province in which the device manufacturer is located.
Manufacturer Country: The country in which the device manufacturer is located.
Reprocessed and Reused Single Use Device: Indicates whether or not the device was a single-use device that was incorrectly reprocessed and reused on a patient.
Single Use Device: Indicates whether the device is labeled for single use or not.
Remedial Action: Follow-up actions taken by the device manufacturer at the time they received the report, if applicable.
Previous Use: Whether the event from the suspected medical device occurred during the initial use, reuse, or unknown.
Removal Correction Number: The number corresponding to the corrective action–if any–reported to the FDA, and can include the recall number if the FDA has assigned one where a firm has not yet submitted a correction or removal report to the FDA.
Product Code: a three-letter code used by the FDA to describe a specific product.
Device Operator: The person using or administering the device at the time of the adverse event.
Brand Name: The trade name or proprietary name of the suspected medical device as used in product labeling or in the catalog. If the suspected device is a reprocessed or reused single-use device, this field will show as ‘NA.’
Type of Device: The general classification of the type of suspected device (e.g. inhaler, urological catheter, heart pacemaker, etc.)
Product Class: The proprietary name or trade name of the cleared device (e.g. infusion pump, insulin pump, etc.)
Device Evaluated by Manufacturer: Whether or not the suspected device was evaluated by the manufacturer
Model Number: The model number is a unique identifier found on the device label or accompanying package that is used to represent the manufacturer, the brand, design, or performance of the device.
Catalog Number: The number used in a catalog to identify a given device.
Device Lot Number: The number associated with a particular quantity or lot of devices from a single manufacturer, if available.
Was Device Available for Evaluation?: Whether or not the device is available for evaluation or returned to the manufacturer.
Device Class: The class defines the security or safety requirements for a device based on the attended use and product codes for the device.
- Class I: A medical device with low to moderate risk that requires general controls. Generally do not require FDA or regulatory approval.
- Class II: A medical device with a moderate to high risk that requires special controls. Generally require FDA approval.
- Class III: A medical device with a high risk that requires premarket approval. Require FDA approval.
Medical Specialty Description: The classification of devices into a specific medical specialty or therapeutic area based on the description and intended use of the device (https://regulatorydoctor.us/fda-medical-device-classification-panels/).
Regulation Number: The number used in accordance with the CFR (Code of Federal Regulations) to identify, describe, and formally classify a device based on various aspects of its design, clinical evaluation, manufacturing, packaging, labeling, and post-market surveillance data.
Outcome: The outcome associated with the adverse event experienced by the patient.
Health Effects: Describes the specific adverse effects on the patient that were observed during the reported event.
Text Type: Describes the narrative provided in the text of the report, whether description of the event/problem, or a narrative from the manufacturer.
PUBLICATIONS: includes over 1.5 million publications from CrossRef in addition to PubMed and arXiv.
Source: The source of the publication as captured in the underlying record (e.g. PubMed, arXiv, crossRef).
Publication Subjects: The general subject or therapeutic focus of the publication.
Published Date: The date on which the publication was published following the formal peer review process–typically the printing or electronic publication date.
Preprint Date: The date on which the article was pre-printed (printed before the formal peer review process).
Author Affiliation Country: The country in which the author’s affiliated organization is located.
Author Affiliation State: The US state in which the author’s affiliated organization is located.
Funder Country: The country in which the funding organization of the publication is located.
Author Name: The legal name of the author or authors of the publication.
Author Affiliation: The organization that the author is affiliated with.
MeSH Headings: Medical Subject Headings thesaurus is a controlled and hierarchically-organized vocabulary produced by the National Library of Medicine (NLM).
MeSH Descriptor: Also used as Main Headings, Descriptors are used to index citations in the National Library of Medicine MEDLINE database and describe the subjects for National Library of Medicine (NLM) catalog records. These descriptors are also searchable in PubMed.
MeSH Qualifier: Also known as a Subheading, Qualifiers are a class in MeSH used to give additional context to a descriptor.
Compounds: (see COMPOUNDS dataset definitions above)
Publisher: The entity who prepares and releases the publication or other works.
Journal Title: The title of the specific journal where the publication was featured.
Funder Name: The name of the agency who provided funding to cover article processing charges (APCs) or book processing charges (BPCs).
Publisher Country: The country where the publishing organization is located.
Publisher State: The US state where the publishing organization is located.
Updated Date: The date that the publication metadata was most recently updated.
Languages: the language of the publication as found in the underlying source data.
TECH TRANSFER: dataset covering nearly 54 thousand tech transfer opportunities sources from over 300 global research universities.
Language: The language of the listed record as per the underlying source data. Typically inferred automatically.
Submitted Date: The date that the record was originally listed by the tech transfer office.
Inventor Name: The name of the individual responsible for creating the IP underlying in the tech transfer opportunity.
Organization Name: The name of the institute, university, or consortium that has listed the tech transfer opportunity.
Country: The country in which the tech transfer office is located.
US State: The US state in which the tech transfer office is located
Continent: The continent on which the tech transfer office is located.
Organization Type: Indicates whether the organization listing the IP is a university, research institute, or consortium.