EU Clinical Trials Regulation (CTR 536/2014): every control, and what you already have

30 controls 4 frameworks share controls with it European Union verified against its source document

Every control below is one this framework asks for. The right hand column counts how many other frameworks in our corpus carry the same control, which is the difference between doing this work once and doing it again for the next standard.

EU Clinical Trials Regulation Evidence & Implementation Kit

30 controls is the documentation set somebody has to write. This is that set, already written: an adopt-ready artifact for every control in policy and procedure text you edit rather than draft, and the evidence checklist an auditor asks for against each.

See what is in it, $249

The same set every buyer of this kit receives. Nothing here is produced on request.

What you already have

Frameworks whose controls overlap this one, most first. If you run any of them, the count is roughly what you have already evidenced.

If you run	Shared controls
ICH E6(R3)	20	measure it →
EU In Vitro Diagnostic Medical Devices Regulation (IVDR)	4	measure it →
GDPR	4	measure it →
EU Medical Devices Regulation (MDR 2017/745)	2	measure it →

Every control

Code	Control	Also in
`CTR-Art.1`	Scope (Article 1)	0
`CTR-Art.10`	Specific considerations for vulnerable populations (Article 10)	1
`CTR-Art.15_16_17`	Substantial modification procedure (Articles 15-17)	1
`CTR-Art.2`	Definitions (Article 2)	0
`CTR-Art.25_26_27`	Application dossier and language requirements (Articles 25-27)	1
`CTR-Art.28`	General rules on subject protection (Article 28)	4
`CTR-Art.29`	Informed consent (Article 29)	3
`CTR-Art.3`	General principle (Article 3)	1
`CTR-Art.31_32`	Trials on incapacitated subjects and minors (Articles 31-32)	1
`CTR-Art.33_34_35`	Pregnant/breastfeeding subjects, additional national measures, emergency trials (Articles 33-35)	1
`CTR-Art.36_37`	Start and end of trial notifications (Articles 36-37)	1
`CTR-Art.38`	Temporary halt or early termination for subject safety (Article 38)	1
`CTR-Art.41_42`	Adverse-event and SUSAR reporting (Articles 41-42)	3
`CTR-Art.43`	Annual safety reporting (Article 43)	1
`CTR-Art.47`	Compliance with the protocol and Good Clinical Practice (Article 47)	1
`CTR-Art.48`	Monitoring (Article 48)	1
`CTR-Art.4_5`	Prior authorisation and submission of application (Articles 4-5)	1
`CTR-Art.52`	Reporting of serious breaches (Article 52)	1
`CTR-Art.57_58`	Clinical trial master file and archiving (Articles 57-58)	1
`CTR-Art.61_62_63`	Manufacturing and import of IMPs and the qualified person (Articles 61-63)	1
`CTR-Art.66_67_68_69`	Labelling of investigational medicinal products (Articles 66-69)	1
`CTR-Art.6_7`	Part I and Part II assessment (Articles 6-7)	0
`CTR-Art.71_72_73_74`	Sponsor, co-sponsorship, principal investigator and legal representative (Articles 71-74)	1
`CTR-Art.76`	Damage compensation (Article 76)	0
`CTR-Art.77_78_79`	Corrective measures, Member State inspections and Union controls (Articles 77-79)	0
`CTR-Art.8`	Decision on the clinical trial (Article 8)	0
`CTR-Art.80_81_82`	EU portal, EU database and functionality (Articles 80-82) - CTIS	2
`CTR-Art.83_84_85`	National contact points, Agency support and Clinical Trials Coordination and Advisory Group (Articles 83-85)	0
`CTR-Art.93`	Data protection (Article 93)	1
`CTR-Art.94`	Penalties (Article 94)	0

Tell me when EU Clinical Trials Regulation (CTR 536/2014) files something new

One email when a public company newly discloses something this framework governs, naming the company and what our corpus says it puts in scope. Nothing else, and one click to stop.

What an auditor will ask you to produce

The artefacts named on the failure modes this framework speaks to.

Corrective-action / withdrawal / recall procedure
Inspection-readiness records (tech doc + QMS + PMS file + vigilance file ready)
Inspection-readiness records (TMF inventory, audit trails, training records, monitoring plan execution)
Corrective-action records following any Member State inspection finding
Inspection-readiness records (technical documentation + QMS + PMS file + vigilance file ready)

How programmes fail on this

Failure modes named by this framework and others. Each opens the full record.

CAPA backlog from prior inspections named by 3 frameworks

What this page is

A control-level reference for EU Clinical Trials Regulation (CTR 536/2014), drawn from our framework corpus. Control codes and titles are references to the standard, not reproductions of it. The overlap counts and the auditor artefacts are our own work and are the part you will not find elsewhere.

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