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Table 3 Quality-related data field for IMPs in clinical trial registry of ICJMEa and WHO-ICTRPb

From: Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Source registry

Intervention or active pharmaceutical ingredient

(Y/N)

Brand

(Y/N)

Manufacturer’s name

(Y/N)

Good Manufacturing Practice certificate

(Y/N)

Good Manufacturing Practice site

(Y/N)

Quality control testing

(Y/N)

Drug regulatory approval

(Y/N)

If yes, approving regulatory authority

(Y/N)

Australian New Zealand Clinical Trials Registry (ANZCTR)c

Y

N

N

N

N

N

N

N

Brazilian Clinical Trials Registry (ReBec)c,d

Y

N

N

N

N

N

N

N

Chinese Clinical Trial Registry (ChiCTR)c,d

Y

N

N

N

N

N

N

N

Clinical Research Information Service Republic of Korea (CRiS)c,d

Y

N

N

N

N

N

N

N

Clinical Trials Registry – India (CTRI)c

Y

N

N

N

N

N

N

N

Cuban Public Registry of Clinical Trials (RPCEC)c

Y

N

N

N

N

N

N

N

EU Clinical Trials Register (EU-CTR)c,d

Y

Y

Y

N

N

N

Y

Y

German Clinical Trials Register (DRKS)d

Y

N

N

N

N

N

N

N

Iranian Registry of Clinical Trials (IRCT)c

Y

N

N

N

N

N

N

N

ISRCTNc

Y

Y

N

N

N

N

N

N

Japan Primary Registries Network (JPRN)c,d

Y

N

N

N

N

N

N

N

Thai Clinical Trials Registry (TCTR)d

Y

N

N

N

N

N

N

N

The Netherlands National Trial Register (NTR)d

Y

N

N

N

N

N

N

N

Pan African Clinical Trials Registry (PACTR)c

Y

N

N

N

N

N

N

N

Peruvian Clinical Trial Registry (REPEC)c

Y

Y

N

N

N

N

N

N

Sri Lanka Clinical Trials Registry (SLCTR)c

Y

N

N

N

N

N

N

N

Clinicaltrials.govd

Y

N

N

N

N

N

N

N

Swiss National Clinical Trials Portal (SNCTP)d

Y

N

N

N

N

N

N

N

Health Canada Clinical Trials Databased

Y

N

N

N

N

N

N

N

  1. aICMJE stands for International Committee for Medical Journals Editors
  2. bWHO-ICTRP stands for WHO International Clinical Trial Registry Platform
  3. cClinical Trial registry of ICTRP
  4. dICMJE-recommended clinical trial registries