- 9/20/21 - 1 form, 12 itemgroups, 101 items, 1 language
Itemgroups: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms
- 5/18/21 - 1 form, 18 itemgroups, 61 items, 1 language
Itemgroups: Administrative, Non-Serious Adverse Event, Non-Serious Adverse Event, Serious Adverse Event (Section 1), Serious Adverse Event (Section 1), Serious Adverse Event - Seriousness (Section 2), Serious Adverse Event - Demography Data (Section 3), Serious Adverse Event - Investigational Product, Serious Adverse Event - Causes (Section 5), Serious Adverse Event - RELEVANT Medical Conditions (Section 6), Serious Adverse Event - Other RELEVANT Risk Factors (Section 7) , Serious Adverse Event - Concomitant Medications (Section 8), Serious Adverse Event - Details of Investigational Product(s) (Section 9), Serious Adverse Event - Details of RELEVANT Assessments (Section 10), Serious Adverse Event - Narrative Remarks (Section 11), SAE - Investigator's signature, Serious Adverse Event (SAE) - Additional/ Follow-up Information, Investigator's Signature (SAE Follow-up)
- 10/17/19 - 1 form, 16 itemgroups, 83 items, 1 language
Itemgroups: Administration, Follow-up studies, Study conclusion, Investigator signature, Tracking Document Safety Follow-Up, Tracking Document Safety Follow-Up , Serious adverse event safety follow-up - Administrative, Serious adverse event safety follow-up, Serious adverse event safety follow-up - Study vaccine information, Serious adverse event safety follow-up - Concomitant medication/ Vaccination that could have contributed to this SAE, Serious adverse event safety follow-up - Relevant intercurrent illness & medical history that could have contributed to this SAE , Serious adverse event safety follow-up - Drug(s) used to treat this SAE , Serious adverse event safety follow-up - Surgical treatment for this SAE , Serious adverse event safety follow-up - Description , Serious adverse event safety follow-up - Comments , Serious adverse event safety follow-up - Investigator signature
- 10/17/19 - 1 form, 16 itemgroups, 76 items, 1 language
Itemgroups: Administration, Concomitant Vaccination, Concomitant Vaccination, Medication, Medication, Non-serious adverse events, Non-serious adverse events, Serious adverse event, Serious adverse event - Study vaccine information, Serious adverse event - Concomitant medication/ Vaccination that could have contributed to this SAE, Serious adverse event - Relevant intercurrent illness & medical history that could have contributed to this SAE, Serious adverse event - Drug(s) used to treat this SAE, Serious adverse event - Surgical treatment for this SAE, SAE - Description, SAE - Comments, Investigator signature

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial