What "following a standard" means
A distinction first, because it is regularly blurred in this field: following a standard means adopting its definitions, names or structure. Being certified means an authorised body has verified that adoption and attested to it.
Good practice and general framework
| Standard | What it normalises | Published by |
|---|---|---|
| ICH E6(R3) | Good clinical practice: data integrity, traceability to source, responsibilities of actors | ICH |
| EQUATOR Network | The directory of reporting guidelines by study type | EQUATOR Network |
| STROBE | Reporting of observational studies: what a paper must state about population, variables and missing data | STROBE Initiative |
Data structure and capture
| Standard | What it normalises | Published by |
|---|---|---|
| CDISC | The family of clinical research data standards | CDISC |
| CDASH | Capture: which variables to collect, under which name, with which definition | CDISC |
| SDTM | The tabulation structure for transmission and submission | CDISC |
| HL7 FHIR | Exchange of health data between systems | HL7 International |
Terminologies and units
| Standard | What it normalises | Published by |
|---|---|---|
| SNOMED CT | A structured clinical terminology: concepts, relationships, hierarchies | SNOMED International |
| LOINC | Identification of laboratory observations and clinical measurements | Regenstrief Institute |
| ICD-10 | The international classification of diseases | World Health Organization |
| UCUM | Unambiguous writing of units of measure | Regenstrief Institute |
The difference between these four is often misunderstood: ICD-10 classifies in order to count, SNOMED CT describes in order to reason, LOINC identifies what is measured, UCUM says in which unit. One datum can carry all four, each answering a different question.
Personal data protection
| Framework | Scope | Authority |
|---|---|---|
| GDPR — Regulation (EU) 2016/679 | Processing under European Union law | National supervisory authorities |
| Law 09-08 | Personal data processing in Morocco, health data included | CNDP |
These two frameworks define, among other things, pseudonymisation and its status: pseudonymised data remains personal data. That is why this site never uses the word "anonymised" in its place.
Reuse and reproducibility
| Standard | What it establishes | Source |
|---|---|---|
| FAIR principles | That research data be findable, accessible, interoperable and reusable — metadata being the condition | Wilkinson et al., *Scientific Data*, 2016 |
The FAIR principles are what justify the delivered dataset comprising six pieces rather than a single table: without a dictionary and metadata, a deposited dataset is reusable by nobody, including the team that produced it.
This site's citation policy
- No citation is invented. Every standard listed here is named with the address of the body that publishes it, verifiable in one click.
- No performance figure is advanced without measurement. This site publishes no adoption rate, no unsourced quantitative comparison, and no clinical result.
- No claim about a competitor without a source. The comparisons address only observable properties of a tool's model.
- Screenshots come from the demonstration account, on fictional data. No figure shown is a result.
Frequent questions
Are these standards mandatory for academic research?
No, none of them. Following them is not a regulatory obligation but a methodological choice: it makes the dataset interoperable, comparable, and legible to someone who does not know the team that produced it.
Is a licence needed to use SNOMED CT?
Access to SNOMED CT depends on the country and the affiliate status of the organisation using it; the terms are published by SNOMED International and should be checked with them rather than assumed.
Where to start if none of these standards is familiar?
With UCUM and CDASH. UCUM because declaring units costs almost nothing and avoids the most expensive errors; CDASH because reusing existing variable names removes the need to invent any, and makes the dataset comparable from day one.