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This is an example CRF used to collect general adverse experiences. This CRF was designed to allow the applicant to use either AEENRF or AEENRTPT to represent an event was ongoing. This form has 2 sections. Section one collects whether a subject expeiences any adverse events, while Section 2 collects a record/row for each adverse experience. Section 1 



Section  2  








This is the metadata specifications for section 1 of the CRF. 


OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were there any adverse experiences? Any Adverse ExperiencesIndicate if the subject experienced any adverse experiences. If Yes, include the appropriate details where indicated on the CRF.TextAEYNN/A
(NY)Yes; No
THis is the metadata specifications for Section 2 of the CRF. 


OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the category of the adverse experience?Adverse Experiences
 Category
Record the adverse experience category, if not pre-printed on the CRF.TextAECATAECAT


Applicant Defined
3What is the subcategory of the adverse experience?Adverse Experience SubcategoryRecord the adverse experience subcategory, if not pre-printed on the CRF.TextAESCATAESCAT


Applicant Defined
4What is the adverse experience identifier?AE NumberIf collected on the CRF, the applicant may insert instructions to ensure each record has a unique identifier.IntegerAESPIDAESPID



5What is the adverse experience term?Adverse ExperiencesRecord only 1 diagnosis, sign, or symptom per line (e.g., nausea and vomiting should not be recorded in the same entry, but as 2 separate entries). Using accepted medical terminology, enter the diagnosis (if known); otherwise, enter a sign or symptom.TextAETERMAETERM



6What is the adverse experience start date?Start DateRecord the start date of the AE using this format (DD-MON-YYYY).DateAESTDATAESTDTC



7Is the adverse experience ongoing?OngoingIndicate if the adverse experience has not resolved at the time of data collection; leave the End Date blank.TextAEONGOAEENRTPT; AEENRFAEENRTPT/ AEENRF(NY)Yes
8What was the adverse experience end date?End DateRecord the date that the AE resolved using this format (DD-MON-YYYY). If the AE is ongoing, leave the field blank.dateAEENDATAEENDTC



9What is the severity of the adverse experience?SeverityThe reporting physician/healthcare professional will assess the severity of the experience using applicant-defined categories. This assessment is subjective, and the reporting physician/healthcare professional should use medical judgment to compare the reported AE to similar type experiences observed in clinical practice. Severity is not equivalent to seriousness.TextAESEVAESEV
(AESEV)MILD; MODERATE; SEVERE
10Was the adverse experience serious?SeriousAssess if an adverse experience should be classified as serious based on the criteria defined in the protocol.TextAESERAESER
(NY)Yes; No
11Did the adverse experience result in death?DeathRecord whether the serious adverse experience resulted in death.TextAESDTHAESDTH
(NY)Yes; No
12What[was the subject’s date of death?Death DateRecord the date of death.dateDTHDATDM.DTHDTC



13Was the adverse experience life-threatening?Life ThreateningRecord whether the serious adverse experience is life-threatening.TextAESLIFEAESLIFE
(NY)Yes; No
14Did the adverse experience result in initial or prolonged hospitalization for the subject?Hospitalization (initial or prolonged)Record whether the serious adverse experience resulted in an initial or prolonged hospitalization.TextAESHOSPAESHOSP
(NY)Yes; No
15Did the adverse experience result in disability or permanent damage?Disability or Permanent DamageRecord whether the serious adverse experience resulted in a persistent or significant disability or incapacity.TextAESDISABAESDISAB
(NY)Yes; No
16Was the adverse experience associated with a congenital anomaly or birth defect?Congenital Anomaly or Birth DefectRecord whether the serious adverse experience was associated with congenital anomaly or birth defect.TextAESCONGAESCONG
(NY)Yes; No
17Did the adverse experience require intervention to prevent permanent impairment or damage resulting from the use of a medical product?Needs Intervention to Prevent ImpairmentRecord whether the serious adverse experience required intervention to prevent permanent impairment or damage due to the use of a medical product.TextAESINTVSUPPAE.QVAL
(NY)Yes; No
18Was the adverse experience a medically important event not covered by other "serious" criteria?Other Serious (Important Medical Events)Record whether the serious adverse experience is an important medical event, which may be defined in the protocol or in the investigator brochure.TextAESMIEAESMIE
(NY)Yes; No
19Was this adverse experience related to study product?Relationship to Study ProductIndicate if the cause of the adverse experience was related to the study product and cannot be reasonably explained by other factors (e.g., subject's clinical state, concomitant therapy, other interventions).TextAERELAEREL

NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED
20What action was taken with the study product?Action Taken with Study ProductRecord changes made to the study intervention resulting from the adverse experience.TextAEACNAEACN
(ACN)DRUG WITHDRAWN; DOSE REDUCED; DOSE INCREASED; DOSE NOT CHANGED; UNKNOWN; NOT APPLICABLE
21What is the outcome of this adverse experience?OutcomeRecord the appropriate outcome of the experience in relation to the subject's status.TextAEOUTAEOUT
(OUT)RECOVERING / RESOLVING; NOT RECOVERED / NOT RESOLVED; RECOVERED / RESOLVED; RECOVERED / RESOLVED WITH SEQUELAE; FATAL  
22What is the action taken with a device?Action Taken with DeviceRecord any action taken with a device as the result of the adverse experience. The device may or may not be a device under study.TextAEACNDEVAEACNDEV
(DEACNDEV)CALIBRATION; REMOVAL; REPROGRAMMING 


23Was this adverse experience related to a device? Relationship of Experience to DeviceRecord the relationship of the adverse experience to DeviceTextAERLDEVAERLDEV

NOT RELATED; UNLIKELY RELATED; POSSIBLY RELATED; RELATED


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