Keywords
Laboratories ×
Eligibility Determination ×
Table of contents
  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
Selected data models

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- 1/14/19 - 1 form, 18 itemgroups, 112 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation, Reason for non participation, Investigator's Data, Use of Human Samples by GSK, Investigator's Signature
- 1/11/19 - 1 form, 23 itemgroups, 137 items, 1 language
Itemgroups: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms
- 10/11/18 - 1 form, 11 itemgroups, 20 items, 1 language
Itemgroups: Administrative documentation, Laboratory test finding, Laboratory Results; Clinical Significance; Unexpected, Antiepileptic Agents; plasma concentration , Laboratory test finding, Laboratory Results; Clinical Significance; Unexpected, Antiepileptic Agents; plasma concentration , Study Subject Participation Status | Assessment Date, Study Subject Participation Status | Inclusion | Exclusion Criteria, Study Subject Participation Status | Inclusion; Seizures; Baseline, Study Subject Participation Status | Clinical Trial Eligibility Criteria