used where details of the Adverse Event are not recorded elsewhere – e.g. within a Study Visit Document. Sponsors’ SAE/ SUSAR Forms, etc., are stored in the CRF rather than the medical notes. Any study document Research Study withdrawal completed as a result of RE05 1054071000000109 / un-blinding withdrawal or un-blinding of a study participant Any other study-specific document that does not Research Study Document RE99 fit into any of the above 1054061000000102 not otherwise specified – categories or for bulk scanning RP Reports RP02 ECG For example ECG 827711000000108 For example, PFT, Sleep RP05 Pulmonary Investigation 822771000000101 tests For example, Carotid, RP08 Vascular Investigation 822781000000104 DVT For example, Breath RP09 Gastro Investigation 822801000000103 tests, PH studies All Cardiac tests except those in RP11 Cardiac Investigation 822791000000102 ECG & Echos e.g. Ambulatory BP For example, Urethral RP12 Urodynamics 827721000000102 function test, Cystometry For example, Carpal RP13 Neuro Investigation tunnel, EEG & nerve 822811000000101 conduction studies For example ePRF Ambulance Patient Report RP29 (Electronic Patient 824861000000106 Form Report Form) RP30 Radiology For example, X-ray, CT 371527006 For example, RP31 Echo 822821000000107 Echocardiogram For example, Hearing RP32 Audiology Investigation 822831000000109 Aids, Tinnitus For example, balance RP33 AHP Investigation 823891000000102 test, swallowing Exercise Tolerance Test RP34 ETT 914861000000106 report Ambulatory ECG For example 24 hour RP35 914851000000108 monitoring report ECG For example Implanted Device maintenance can include RP36 918401000000103 Maintenance Report device check, replacement of leads,
used where details of the Adverse Event are not recorded elsewhere – e.g. within a Study Visit Document. Sponsors’ SAE/ SUSAR Forms, etc., are stored in the CRF rather than the medical notes. RE05 Research Study withdrawal / un-blinding Any study document completed as a result of withdrawal or un-blinding of a study participant 1054071000000109 RE99 Research Study Document – not otherwise specified Any other study-specific document that does not fit into any of the above categories or for bulk scanning 1054061000000102 RP Reports RP02 ECG For example ECG 827711000000108 RP05 Pulmonary Investigation For example, PFT, Sleep tests 822771000000101 RP08 Vascular Investigation For example, Carotid, DVT 822781000000104 RP09 Gastro Investigation For example, Breath tests, PH studies 822801000000103 RP11 Cardiac Investigation All Cardiac tests except those in ECG & Echos e.g. Ambulatory BP 822791000000102 RP12 Urodynamics For example, Urethral function test, Cystometry 827721000000102 RP13 Neuro Investigation For example, Carpal tunnel, EEG & nerve conduction studies 822811000000101 RP29 Ambulance Patient Report Form For example ePRF (Electronic Patient Report Form) 824861000000106 RP30 Radiology For example, X-ray, CT 371527006 RP31 Echo For example, Echocardiogram 822821000000107 RP32 Audiology Investigation For example, Hearing Aids, Tinnitus 822831000000109 RP33 AHP Investigation For example, balance test, swallowing 823891000000102 RP34 ETT Exercise Tolerance Test report 914861000000106 RP35 Ambulatory ECG monitoring report For example 24 hour ECG 914851000000108 RP36 Implanted Device Maintenance Report For example maintenance can include device check, replacement of leads, 918401000000103
2018-04-27-CDI-Standard-v3-3-FINAL.docx