Study Type

Resources:

  • See the full metadata model in PDF or Markdown.
  • See the Study Type element of the full metadata model.
  • See guidance to respond to each field, and their use cases, by clicking the arrow to the left of the bold field names below.

Fill out this section of the CEDAR form:

Expand the Study Type section. This section has five fields; click below to expand guidance for each field.

Category or Type/Stage of Study Research

How to answer

This field allows multiple answer selections. Select all that apply. Possible answers include:

  • Pre-Research/Protocol Development
  • Basic Research
  • Pre-Clinical Research
  • Clinical Research
  • Implementation Research
  • Post-market Research
  • Business Development
  • Epidemiologic Research.

If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, and will allow users to quickly find broad, relevant studies, study data, or study-generated knowledge. For example:

  • Clinical Research: A pain patient may seek novel treatments currently at the clinical trial stage.
  • Post-market Research: An OUD patient on an MOUD, who is experiencing unexpected side-effects, may look for study information on efficacy and side effects of their drug “in the real world.”
  • Implementation Research: A clinician or health system may search for best practices to implement a promising new treatment or clinical process for their pain patients.
Is the study conducting primary or secondary research?

How to answer

This field allows a single answer selection of “Primary Research” or “Secondary Research.”

  • Primary Research: Your study will collect primary data (i.e. measurements to generate data to address the study research question) OR conduct an active experiment.
  • Secondary Research: Your study will NOT collect primary data AND your study will NOT conduct an active experiment. If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, and will allow Platform users to quickly find broad, relevant studies, study data, or study-generated knowledge. For example:

  • Primary Research: A researcher requiring primary research data or results to leverage for a secondary research study, such as a meta-analysis or natural experiment
  • Secondary Research: A journalist seeking secondary research examples, enabled by the HEAL Initiative/HEAL Platform, for a story on data re-use and collaborative science making a difference for individuals and communities impacted by OUD and pain conditions.
Is the study conducting observational or experimental research?

How to answer

This field allows a single answer: “Observational Research” or “Experimental Research.”

  • Observational Research: If your study will NOT conduct an active experiment (e.g. actively or passively collecting measurements without any intervention, or in the context of a naturally occurring intervention - a “natural experiment”), select “Observational Research."
  • Experimental Research: If your study will conduct an active experiment, select “Experimental Research." If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, and will allow users to quickly locate broad, relevant studies, study data, or study-generated knowledge.

Study Subject Type

How to answer

This field allows multiple answer selections from a response set, including:

  • Human
  • Animal
  • Human cell/tissue/tissue model
  • Animal cell/tissue/tissue model
  • Molecule

Select all that apply. For example:

  • Human studies treat or observe individuals or communities of human subjects (e.g. a clinical trial, cross sectional survey, prospective cohort study, clinical process implementation trial, community-based cluster randomized control trial, etc.).
  • Animal studies treat or observe animals or animal models (e.g. mice, zebrafish, drosophila).
  • Human cell/tissue/tissue model OR Animal cell/tissue/tissue model studies treat or observe human or animal cells (primary or cultured).
  • Molecule studies treat or observe molecules (e.g. enzymology, chemical/protein binding or engineering, protein crystallization, etc.).
  • For computational studies, consider your subject of interest (e.g. modeling humans, human interaction, molecules, or molecular interactions). If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

How this field will be used

These values will likely be filterable under “Advanced Search'' on the HEAL Platform Discovery page, and will allow users to quickly find broad, relevant studies, study data, or study-generated knowledge. For example:

  • Animal: A researcher studying mice to investigate mechanisms of a novel OUD relapse drug treatments, seeks analogous studies in other model organisms.
  • Animal and Human cell/tissue/tissue model: A researcher developing a first stage I clinical trial for a novel chronic pain treatment drug, wants to collate all drug research and data (animal studies and in vitro studies in human cells) to decide on a dosing schedule and assays to test efficacy and safety.
  • Molecule: A researcher who has unearthed a potential new druggable molecular target to treat acute opioid overdose, wants to know if anyone else has studied the enzymology, crystal structure, etc. of this target.
Study Type/Design

How to answer

This field allows multiple selections. Select all that apply. If these do not apply, skip the question, or contact heal-support@gen3.org for questions or support.

How this field will be used

These values will likely be filterable under “Advanced Search” on the HEAL Platform Discovery page, and will allow users to quickly find broad, relevant studies, study data, or study-generated knowledge.

Once complete, collapse the Study Type section and save your form.