0.1.1 - ci-build
ScheduleOfActivityIG - Local Development build (v0.1.1). See the Directory of published versions
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
Example Design Instances for H2Q-MC-LZZT
H2Q-MC-LZZT-ProtocolDesign |
H2Q-MC-LZZT-Protocol Schedule of Activities |
H2Q-MC-LZZT Research Study |
Xanomeline (LY246708)Protocol H2Q-MC-LZZT(c)Safety and Efficacy of the Xanomeline Transdermal Therapeutic System (TTS) in Patients with Mild to Moderate Alzheimer’s Disease |
H2Q-MC-LZZT Exclusion Criteria |
H2Q-MC-LZZT Exclusion Criteria |
H2Q-MC-LZZT Inclusion Criteria |
H2Q-MC-LZZT Inclusion Criteria |
ET-14 |
Planned Visit [ET-14] |
RT-15 |
Planned Visit [RT-15] |
Visit-1 |
Planned Visit [Visit-1] |
Visit-10 |
Planned Visit [Visit-10] |
Visit-11 |
Planned Visit [Visit-11] |
Visit-12 |
Planned Visit [Visit-12] |
Visit-13 |
Planned Visit [Visit-13] |
Visit-2 |
Planned Visit [Visit-2] |
Visit-3 |
Planned Visit [Visit-3] |
Visit-4 |
Planned Visit [Visit-4] |
Visit-5 |
Planned Visit [Visit-5] |
Visit-6 |
Planned Visit [Visit-6] |
Visit-7 |
Planned Visit [Visit-7] |
Visit-8 |
Planned Visit [Visit-8] |
Visit-9 |
Planned Visit [Visit-9] - removed in Protocol Amendment |
Study Actors
Eli Lilly and Company |
Samuel Home, M.D. |
Study Activities
ADAS-Cog |
Planned Activity [ADAS-Cog] |
Adverse events |
Planned Activity [Adverse events] |
Ambulatory ECG placed |
Planned Activity [Ambulatory ECG placed] |
Ambulatory ECG removed |
Planned Activity [Ambulatory ECG removed] |
Apo E genotyping |
Planned Activity [Apo E genotyping] |
CIBIC+ |
Planned Activity [CIBIC+] |
CT Scan |
Planned Activity [CT Scan] |
Chest x-ray |
Planned Activity [Chest x-ray] |
Concomitant Medications |
Planned Activity [Concomitant Medications] |
DAD |
Planned Activity [DAD] |
ECG |
Planned Activity [ECG] |
Habits - Alcohol |
Planned Activity [Habits - Alcohol] |
Habits - Caffeine |
Planned Activity [Habits - Caffeine] |
Habits - Smoking |
Planned Activity [Habits - Smoking] |
Hachinski 4 |
Planned Activity [Hachinski 4] |
Hemoglobin A1C |
Planned Activity [Hemoglobin A1C] |
Informed Consent |
Planned Activity [Informed Consent] |
Laboratory (Chem) |
Planned Activity [Laboratory (Chem)] |
Laboratory (Hemat) |
Planned Activity [Laboratory (Hemat)] |
Laboratory (Urinalysis) |
Planned Activity [Laboratory (Urinalysis)] |
MMSE 10-23 |
Planned Activity [MMSE 10-23] |
Medical History |
Planned Activity [Medical History] |
Medications dispensed |
Planned Activity [Medications dispensed] |
Medications returned |
Planned Activity [Medications returned] |
NPI-X |
Planned Activity [NPI-X] |
Patient number assigned |
Planned Activity [Patient number assigned] |
Patient randomized |
Planned Activity [Patient randomized] |
Physical examination |
Planned Activity [Physical examination] |
Placebo TTS test |
Planned Activity [Placebo TTS test] |
Plasma Specimen |
Planned Activity [Plasma Specimen] |
Study drug record |
Planned Activity [Study drug record] |
TTS Acceptability Survey |
Planned Activity [TTS Acceptability Survey] |
Visit Date |
Planned Activity [Record Visit Date] |
Vital signs/Temperature |
Planned Activity [Vital signs/Temperature] |
Study Observations
ADAS-Cog-Observations |
Planned Observation(s) [ADAS-Cog] |
Adverse events-Observations |
Planned Observation(s) [Adverse events] |
Ambulatory ECG placed-Observations |
Planned Observation(s) [Ambulatory ECG placed] |
Ambulatory ECG removed-Observations |
Planned Observation(s) [Ambulatory ECG removed] |
Apo E genotyping-Observations |
Planned Observation(s) [Apo E genotyping] |
CIBIC+-Observations |
Planned Observation(s) [CIBIC+] |
CT Scan-Observations |
Planned Observation(s) [CT Scan] |
Chest x-ray-Observations |
Planned Observation(s) [Chest x-ray] |
Concomitant Medications-Observations |
Planned Observation(s) [Concomitant Medications] |
DAD-Observations |
Planned Observation(s) [DAD] |
ECG-Observations |
Planned Observation(s) [ECG] |
Habits-Observations |
Planned Observation(s) [Habits] |
Hachinski 4-Observations |
Planned Observation(s) [Hachinski 4] |
Hemoglobin A1C-Observations |
Planned Observation(s) [Hemoglobin A1C] |
Informed Consent-Observations |
Planned Observation(s) [Informed Consent] |
Laboratory (Chem/Hemat)-Observations |
Planned Observation(s) [Laboratory (Chem/Hemat)] |
Laboratory (Urinalysis)-Observations |
Planned Observation(s) [Laboratory (Urinalysis)] |
MMSE 10-23-Observations |
Planned Observation(s) [MMSE 10-23] |
Medical History-Observations |
Planned Observation(s) [Medical History] |
Medications dispensed-Observations |
Planned Observation(s) [Medications dispensed] |
Medications returned-Observations |
Planned Observation(s) [Medications returned] |
NPI-X-Observations |
Planned Observation(s) [NPI-X] |
Patient number assigned-Observations |
Planned Observation(s) [Patient number assigned] |
Patient randomized-Observations |
Planned Observation(s) [Patient randomized] |
Physical examination-Observations |
Planned Observation(s) [Physical examination] |
Placebo TTS test-Observations |
Planned Observation(s) [Placebo TTS test] |
Plasma Specimen-Observations |
Planned Observation(s) [Plasma Specimen] |
Study drug record-Observations |
Planned Observation(s) [Study drug record] |
TTS Acceptability Survey-Observations |
Planned Observation(s) [TTS Acceptability Survey] |
Vital signs/Temperature-Observations |
Planned Observation(s) [Vital signs/Temperature] |
Deliverables for H2Q-MC-LZZT
H2Q-MC-LZZT Bundle 1 |
First Deliverable for the PHUSE Project |
H2Q-MC-LZZT Bundle 2 |
Second Deliverable for the PHUSE Project |
These define constraints on FHIR resources for systems conforming to this implementation guide
Research Study Inclusion Exclusion |
Research Study Inclusion Exclusion Criteria |
SOA Arm Definition |
Extension to define a Arm Group for a Research Study |
SOA Epoch Defintion |
An example of a study epoch definition for the study. |
SOA PlanDefinition |
Schedule of Activities PlanDefinition Extensions |
SOA Planned Visit Definition |
An example of a planned visit definition for the study. |
SOA Protocol Plan Defintion |
A profile on the plan definition resource to define the events in a protocol. |
SOA Planned Study Activity Definition |
Planned Study Activity Definition that allows tagging of milestones |
SOA Study Defintion |
An example of the plan definition for the study. |
SOA Subject |
A research subject example. |
SOA Unplanned Visit Definition |
An example of a unplanned visit definition for the study. |
SOA Visit Plan Defintion |
A profile on the plan definition resource to define the planned events for a visit. |
These define constraints on FHIR data types for systems conforming to this implementation guide
ResearchStudy Arm |
Reference to Study for Study Arm |
Arm Status |
Set of permitted values for Arm status |
Planned Study Day of Visit |
Planned Study Day of Visit, such as Day -21, Day 1, Day 52 |
Planned Study Day Window |
Planned Study Day Window (Times) |
Planned Study Offset of Visit |
Planned Study Offset of Visit |
Planned Study Window of Visit |
Planned Study Window of Visit |
Epoch Type |
Categorization of Epoch Type |
Study Milestone |
Categorization of Study Milestone |
Study Event OID |
OID for Study Event in Design |
Unplanned Study Visit Range |
Unplanned Study Visit Range [Day.min() to Day.max() of SoA] |
These define sets of codes used by systems conforming to this implementation guide
Arm Status Value Set |
Set of permitted values for Arm status |
Epoch Type Value Set |
Set of permitted values for Epoch |
Study Milestone |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like
Vital Signs/Temperature |
Planned Activity [Vital signs/Temperature] |
Temperature Measurement |
Temperature Measurement |
Temperature Measurement - Observation |
Observation of Temperature Measurement |
Temperature-Observation |
Planned Observation [Temperature] |
Temperature-Observation |
Planned Observation [Temperature] |
VitalSigns-Observation |
Planned Observation [VitalSigns] |
Vitalsigns-HeartRate-Blood-Pressure |
Vital signs blood pressure and heart rate (repeated) |