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← eCTD Controlled Vocabularies

Document type

Classifies the type of a referenced document (e.g. SmPC, labelling, PIL). Used as a keyword on a Context of Use.

eCTD 4.0 Document type 93 terms
All agencies EMA FDA ICH SwissMedic
Term Code Agency Status
preclinical study report ich_document_type_1 ICH Active
list patients with batches ich_document_type_10 ICH Active
randomisation scheme ich_document_type_11 ICH Active
audit certificates report ich_document_type_12 ICH Active
statistical methods interim analysis plan ich_document_type_13 ICH Active
inter-laboratory standardisation methods quality assurance ich_document_type_14 ICH Active
publications based on study ich_document_type_15 ICH Active
publications referenced in report ich_document_type_16 ICH Active
discontinued patients ich_document_type_17 ICH Active
protocol deviations ich_document_type_18 ICH Active
patients excluded from efficacy analysis ich_document_type_19 ICH Active
legacy clinical study report ich_document_type_2 ICH Active
demographic data ich_document_type_20 ICH Active
compliance and drug concentration data ich_document_type_21 ICH Active
individual efficacy response data ich_document_type_22 ICH Active
adverse event listings ich_document_type_23 ICH Active
listing individual laboratory measurements by patient ich_document_type_24 ICH Active
case report forms ich_document_type_25 ICH Active
available on request ich_document_type_26 ICH Active
assay validation ich_document_type_27 ICH Active
biomarkers ich_document_type_28 ICH Active
data monitoring review committees ich_document_type_29 ICH Active
synopsis ich_document_type_3 ICH Active
device information ich_document_type_30 ICH Active
diagnostic tests ich_document_type_31 ICH Active
gene therapy ich_document_type_32 ICH Active
patient reported outcomes ich_document_type_33 ICH Active
pharmacodynamics ich_document_type_34 ICH Active
pharmacogenomics ich_document_type_35 ICH Active
pharmacokinetics ich_document_type_36 ICH Active
quality of life ich_document_type_37 ICH Active
stem cells ich_document_type_38 ICH Active
abuse liability ich_document_type_39 ICH Active
study report body ich_document_type_4 ICH Active
antibody ich_document_type_40 ICH Active
healthcare utilization ich_document_type_41 ICH Active
other data not specified ich_document_type_42 ICH Active
pk/pd relationship ich_document_type_43 ICH Active
specialty report ich_document_type_44 ICH Active
bimo ich_document_type_45 ICH Active
foreign clinical studies not under ind ich_document_type_46 ICH Active
data tabulation dataset legacy ich_document_type_47 ICH Active
data tabulation data definition ich_document_type_48 ICH Active
data listing dataset ich_document_type_49 ICH Active
protocol or amendment ich_document_type_5 ICH Active
data listing data definition ich_document_type_50 ICH Active
analysis dataset legacy ich_document_type_51 ICH Active
analysis program ich_document_type_52 ICH Active
analysis data definition ich_document_type_53 ICH Active
annotated crf ich_document_type_54 ICH Active
ecg ich_document_type_55 ICH Active
image ich_document_type_56 ICH Active
subject profiles ich_document_type_57 ICH Active
safety report ich_document_type_58 ICH Active
antibacterial ich_document_type_59 ICH Active
sample case report form ich_document_type_6 ICH Active
special pathogen ich_document_type_60 ICH Active
antiviral ich_document_type_61 ICH Active
iss ich_document_type_62 ICH Active
ise ich_document_type_63 ICH Active
pm description ich_document_type_64 ICH Active
study data reviewer's guide ich_document_type_66 ICH Active
analysis data reviewer's guide ich_document_type_67 ICH Active
hf validation protocol ich_document_type_68 ICH Active
hf validation report ich_document_type_69 ICH Active
iec irb consent form list ich_document_type_7 ICH Active
hf validation other ich_document_type_70 ICH Active
data tabulation dataset sdtm ich_document_type_71 ICH Active
data tabulation dataset send ich_document_type_72 ICH Active
analysis dataset adam ich_document_type_73 ICH Active
csr other ich_document_type_74 ICH Active
hepatic impairment study? ich_document_type_75 ICH Active
renal impairment study? ich_document_type_76 ICH Active
drug-drug interaction study? ich_document_type_77 ICH Active
mass balance study? ich_document_type_78 ICH Active
population pk report? ich_document_type_79 ICH Active
list description investigator site ich_document_type_8 ICH Active
population pkpd report? ich_document_type_80 ICH Active
pbpk report? ich_document_type_81 ICH Active
pbbm report? ich_document_type_82 ICH Active
qsp report? ich_document_type_83 ICH Active
cp general? ich_document_type_84 ICH Active
qt clinical study? ich_document_type_85 ICH Active
qt invitro study? ich_document_type_86 ICH Active
pd invivo study? ich_document_type_87 ICH Active
pd invitro study? ich_document_type_88 ICH Active
iscp? ich_document_type_89 ICH Active
signatures investigators ich_document_type_9 ICH Active
isi? ich_document_type_90 ICH Active
weight of evidence? ich_document_type_91 ICH Active
animal rule efficacy? ich_document_type_92 ICH Active
animal rule natural history? ich_document_type_93 ICH Active
nonstandard safety study? ich_document_type_94 ICH Active

93 terms shown for ICH. Data sourced from public health authority publications and updated periodically.