replace
Triage: Uncategorized /protocolSection/designModule/studyType Before
INTERVENTIONAL
After
OBSERVATIONAL
NCT00165256
Version 6 to 7 · Dana-Farber Cancer Institute
Patch inspector
Manual review pending.
arms_or_interventions_changedesign_info_changephase_change None recorded.
d95f21c702e7a9fd2ff29f17da4da37af7c0a5a16c90dd54bbfa4aa581bd5536/protocolSection/designModule/studyType INTERVENTIONAL
OBSERVATIONAL
/protocolSection/designModule/phases phase_change Trial phase changes are high review-priority design changes. [ "PHASE2" ]
/protocolSection/designModule/designInfo/allocation design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. NA
/protocolSection/designModule/designInfo/interventionModel design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. SINGLE_GROUP
/protocolSection/designModule/designInfo/maskingInfo design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. {
"masking": "NONE"
} /protocolSection/designModule/designInfo/observationalModel design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. CASE_ONLY
/protocolSection/designModule/designInfo/timePerspective design_info_change Design information changes can alter allocation, masking, model, or purpose and need review. PROSPECTIVE
/protocolSection/designModule/patientRegistry false
/protocolSection/armsInterventionsModule/armGroups/0/type arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure. EXPERIMENTAL
/protocolSection/statusModule/lastUpdateSubmitDate 2016-07-01
2016-07-05
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2016-07-04
2016-07-06
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2016-07-05"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2016-07-06"
},
{
"op": "replace",
"path": "/protocolSection/designModule/studyType",
"value": "OBSERVATIONAL"
},
{
"op": "remove",
"path": "/protocolSection/designModule/phases"
},
{
"op": "remove",
"path": "/protocolSection/designModule/designInfo/allocation"
},
{
"op": "remove",
"path": "/protocolSection/designModule/designInfo/interventionModel"
},
{
"op": "remove",
"path": "/protocolSection/designModule/designInfo/maskingInfo"
},
{
"op": "add",
"path": "/protocolSection/designModule/designInfo/observationalModel",
"value": "CASE_ONLY"
},
{
"op": "add",
"path": "/protocolSection/designModule/designInfo/timePerspective",
"value": "PROSPECTIVE"
},
{
"op": "add",
"path": "/protocolSection/designModule/patientRegistry",
"value": false
},
{
"op": "remove",
"path": "/protocolSection/armsInterventionsModule/armGroups/0/type"
}
]