Interventions

Make the studied thing explicit

flowchart LR
    Scattered[Scattered intervention context] --> Intervention[Intervention record]
    Intervention --> Science[Scientific clarity]
    Intervention --> Operations[Operational readiness]
    Intervention --> Connections[Trial and media links]

Teams rarely fail because they have no knowledge of what is being studied. They fail because scientific characteristics, regulatory classification, and storage requirements live in scattered documents with no single governed record.

An intervention record gives the team one durable place to answer questions such as:

• what is this intervention and what type is it
• who sponsors it and how is it identified
• what regulatory classification and subtype data apply
• what are the scientific or technical characteristics for this type
• what storage conditions and handling constraints matter downstream

That matters because trial execution depends on whether the intervention is scientifically described and operationally ready, not just whether a name appears in a protocol.

Support science and operations together

flowchart LR
    Intervention[Intervention] --> Trials[Trials]
    Intervention --> Media[Supporting media]
    Intervention --> Sponsors[Sponsor organizations]

The intervention page holds both scientific meaning and execution detail. Different intervention types surface different sections — a drug shows pharmacological targets and storage conditions, a device shows technical specifications and safety classifications, a behavioral intervention shows modality and provider context.

Type-specific pages

Different intervention types do not share the same form contract. Use the child pages below when you need the exact fields for a specific intervention type.

Intervention type	Extra sections beyond basics and identifiers	Child page
Drug	Regulatory, science, storage, handling	Drug
Biological	Regulatory, science, storage, handling	Biological
Device	Regulatory, science, storage, handling	Device
Diagnostic	Regulatory, science	Diagnostic
Dietary Supplement	Storage, handling	Dietary Supplement
Procedure	Procedure	Procedure
Behavioral	Behavioral	Behavioral
Radiation	Science	Radiation
Genetic	Science	Genetic
Combination Product	Storage, handling	Combination Product
Other	No additional sections today	Other

Put interventions to work

flowchart LR
    Intervention[Intervention record] --> Identify[Establish identity and type]
    Intervention --> Classify[Regulatory classification]
    Intervention --> Describe[Scientific characteristics]
    Intervention --> Store[Storage conditions]
    Intervention --> Handle[Handling requirements]

The page is especially useful when a team needs to:

• establish the intervention identity with name, type, and sponsor context
• track formal identifiers such as NDC, UDI, or internal codes
• capture regulatory classification details that vary by intervention type
• describe scientific characteristics specific to the intervention category
• document storage conditions including temperature, light sensitivity, and shelf life
• specify handling requirements including cold chain and special handling

On the page

The intervention page is section-based. Some sections appear conditionally based on the selected intervention type — drug, biologic, device, diagnostic, procedure, behavioral, radiation, or genetic.

Surface	Purpose	What users do there
Summary	Maintain intervention identity, science, and logistics	Capture name, type, classification, characteristics, storage, handling
Relationship tabs	Keep operational context visible	Review linked trials, media

classDiagram
    class InterventionPage {
        +Summary
        +RelationshipTabs
    }

    class Summary {
        +Basics
        +Identifiers
        +RegulatoryClassification
        +ScientificCharacteristics
        +Procedure
        +Behavioral
        +Storage
        +Handling
    }

    class RelationshipTabs {
        +Trials
        +Media
    }

    InterventionPage *-- Summary
    InterventionPage *-- RelationshipTabs

What to capture

mindmap
  root((Strong intervention records))
    Clear identity and type
    Formal identifiers
    Regulatory classification
    Type-specific scientific characteristics
    Storage conditions
    Handling requirements

A strong intervention record is not just a name and category. It makes clear whether the studied element is scientifically described and operationally ready for downstream trial work.

Good intervention records usually do five things well:

• they establish a clear identity with type, sponsors, and description
• they carry formal identifiers that trace the intervention across systems
• they capture regulatory classification detail appropriate to the type
• they describe the scientific or technical characteristics relevant to the specific category
• they document storage and handling requirements so operational readiness is never in question

That is why only Name is required. The point is to capture the context that supports real downstream decisions, and the right depth depends on the intervention type.

Basics

mindmap
  root((Basics))
    Name
    Intervention type
    Sponsors
    Description

This section establishes what the intervention is.

Label	Description	Type
Name	Primary name of the intervention	Text
Intervention Type	Category such as drug, biologic, device, diagnostic, procedure, behavioral, radiation, genetic	Select
Sponsors	Organizations that sponsor or manufacture the intervention	Multi-select
Description	Free-form description of the intervention	Rich text

Identifiers

mindmap
  root((Identifiers))
    Type badge
    Value

This section tracks formal identifiers such as NDC codes, UDI numbers, or internal reference codes. Rows can be reordered.

Label	Description	Type
Type	Identifier type such as NDC, UDI, Internal	Select badge
Value	The identifier value	Text

Regulatory Classification

mindmap
  root((Regulatory Classification))
    Drug and biologic fields
    Device fields
    Diagnostic fields

This section captures regulatory classification details. The visible fields depend on the selected intervention type.

For the exact per-type field lists, use the intervention type child pages above. The parent intervention page stays focused on the shared mental model and overall surface.

Drug / Biologic fields

Label	Description	Type
Regulatory Status	Current regulatory approval status	Select
Drug Schedule	DEA schedule classification	Select
Route of Administration	How the intervention is administered	Select
Dosage Form	Physical form such as tablet, injection, capsule	Select
Strength	Dosage strength with unit	Text
ATC Code	Anatomical Therapeutic Chemical classification code	Text
Pharmacological Class	Pharmacological class or therapeutic category	Text
INN	International Nonproprietary Name	Text
Brand Name	Marketed brand name	Text

Device fields

Label	Description	Type
Device Class	FDA device classification (I, II, III)	Select
Product Code	FDA product code	Text
Regulation Number	Applicable regulation number	Text
Submission Type	Regulatory submission pathway such as 510(k), PMA	Select
GMDN Code	Global Medical Device Nomenclature code	Text
GMDN Term	GMDN descriptive term	Text

Diagnostic fields

Label	Description	Type
Assay Type	Type of diagnostic assay	Select
Specimen Type	Required specimen type	Select
Analyte	Target analyte or biomarker	Text

Scientific Characteristics

mindmap
  root((Scientific Characteristics))
    Drug and biologic targets
    Device technical specs
    Diagnostic performance
    Radiation parameters
    Genetic technique

This section captures the scientific or technical characteristics specific to the intervention type. The visible fields depend on the selected type.

Drug / Biologic fields

Label	Description	Type
Mechanism of Action	How the intervention produces its effect	Rich text
Target	Molecular or biological target	Text
Half-Life	Pharmacokinetic half-life	Text
Bioavailability	Percentage of drug reaching systemic circulation	Text
Metabolism	Metabolic pathway information	Text
Is Biosimilar	Whether the biologic is a biosimilar	Toggle
Is Combination Product	Whether this is a combination product	Toggle

Device fields

Label	Description	Type
Power Source	Device power source type	Select
Materials	Materials used in the device	Text
Software Version	Current software version if applicable	Text
Sterilization Method	Method of sterilization	Select
Is Implantable	Whether the device is implanted	Toggle
Is Reusable	Whether the device can be reused	Toggle
Has Software	Whether the device contains software	Toggle

Diagnostic fields

Label	Description	Type
Sensitivity	Diagnostic sensitivity percentage	Text
Specificity	Diagnostic specificity percentage	Text
Turnaround Time	Time to results	Text
Is Point of Care	Whether this is a point-of-care diagnostic	Toggle
Requires Lab	Whether lab processing is needed	Toggle

Radiation fields

Label	Description	Type
Radiation Type	Type of radiation used	Select
Energy Level	Radiation energy level	Text
Fractionation Schedule	How doses are divided over time	Text
Total Dose	Total planned radiation dose	Text
Is Image Guided	Whether image guidance is used	Toggle

Genetic fields

Label	Description	Type
Technique	Genetic technique such as CRISPR, gene therapy, antisense	Select
Target Gene	Target gene or genetic element	Text
Vector Type	Delivery vector type	Select
Is Ex Vivo	Whether modification occurs outside the body	Toggle

Procedure

mindmap
  root((Procedure))
    Procedure type
    Anesthesia required
    Description

This section appears for procedure-type interventions and captures surgical or procedural delivery context.

Label	Description	Type
Procedure Type	Category of procedure	Select
Anesthesia Required	Whether anesthesia is needed	Toggle
Procedure Description	Detailed description of the procedure	Rich text

Behavioral

mindmap
  root((Behavioral))
    Modality
    Provider type
    Description

This section appears for behavioral-type interventions and captures delivery modality and provider context.

Label	Description	Type
Modality	Delivery modality such as individual, group, digital	Select
Provider Type	Type of provider delivering the intervention	Select
Intervention Description	Detailed description of the behavioral intervention	Rich text

Storage

mindmap
  root((Storage))
    Category
    Temperature range
    Light and container
    Shelf life
    Freeze and refrigeration flags

This section captures storage condition requirements.

Label	Description	Type
Category	Storage classification category	Select
Regulatory Reference	Applicable storage regulation or guideline	Text
Temperature Minimum	Minimum storage temperature	Number
Temperature Maximum	Maximum storage temperature	Number
Temperature Target	Ideal target temperature	Number
Temperature Unit	Unit of measurement for temperature	Select
Light Sensitivity	Whether the product is light-sensitive	Select
Container Type	Required container or packaging type	Select
Shelf Life Value	Numeric shelf life duration	Number
Shelf Life Unit	Unit for shelf life such as days, months, years	Select
Do Not Freeze	Whether freezing must be avoided	Toggle
Do Not Refrigerate	Whether refrigeration must be avoided	Toggle
Desiccant Required	Whether a desiccant is needed	Toggle

Handling

mindmap
  root((Handling))
    Cold chain monitoring
    Special handling requirements
    Validated shipper
    Additional instructions

This section captures handling requirements that affect downstream logistics.

Label	Description	Type
Cold Chain Monitoring	Cold chain monitoring approach	Select
Special Handling	Special handling requirements	Multi-select
Additional Instructions	Free-form handling instructions	Rich text
Cold Chain Required	Whether cold chain is mandatory	Toggle
Requires Validated Shipper	Whether a validated shipper is needed	Toggle