PhUSE
Heidelberg, Germany – 12 October 05
The Future of CDISC
Rebecca D. Kush, PhD
Founder and President, CDISC
The Future of CDISC
• The Remainder of 2005 (Q4)
• The CDISC Technical Roadmap (2006-08)
• Strategic Plans for the CDISC Future
2
CDISC Teams and Projects - 2005
CDISC Technical Coordinating Committee
Single
Source
HL7-CDISC Harmonization; Domain Analysis Model
eSource
Data
Interchange
Metadata – end-to-end consistency
LAB and AE scenarios
eCRF
HL7 V3
Define.xml
Terminology (Codelists)
CV Stds
TB Stds
PRG
ODM
LAB
SDS
SEND
ADaM
OPS: Maintenance, Member Relations, Education and Implementation Groups, Glossary
3
Team; X-team
Projects
Standard
Implementation
Version Release
Date
SDTM, SEND
Ready for regulatory submission of CRT
4,000 downloads as of mid-2005
2004*
ODM
CDISC Transport Standard for acquisition,
exchange, submission (define.xml) and
archive
2001
LAB
Content standard – available for transfer
of clinical lab data to sponsors
2002
ADaM
General Considerations document and
examples of datasets for submission
2004
Protocol
Representation
Collaborative effort to develop machinereadable standard protocol with data layer
In progress
Terminology
Codelists
Developing standard terminology to
support all CDISC standards
In progress
Define.xml
Case Report Tabulation Data Definition
Specification
2005*
Metadata
End-to-end
(Harmonization activity among standards)
– CDISC Roadmap
In progress
* Specification on FDA Guidance
4
Q4 CDISC Team Goals
• SDTM
– SDTM IG 3.1.1 final released Sept 05; support implementations of SDTM
• SEND
– Pilots for reproductive toxicity data in progress; likely to be released as
separate IG
– Working with SDS on PK domains
• ODM
– Version 1.3 to be released by December 2005
– Collaborating with NCI on HL7 Message for eData Collection Instrument
(e.g. eCRF)
• ADaM
– Completing analysis dataset examples
– Collaborating with SDTM on SDTM-ADaM Pilot
• LAB
– 1.1.0 update in progress (due Q4)
– SDS Lab TESTCD names to be released Q4.
5
Terminology (Vocabulary)
A pillar of interoperability
CDISC
HL7
FDA
Identified
All SDTM variables
Defined
Possible attributes of proposed codelists
Published
1st Package with 32 draft codelist & value proposals
Assigned
Most of the missing
codelists for SDTM variables
DCRI
NCI
VA
6
NIH Grants
• NIH Roadmap contract: BAA-RM-04-23
Re-engineering the Clinical Research Enterprise: Feasibility of Integrating and
Expanding Clinical Research Networks
• Recognition that therapeutic area standards (Cardiovascular and
Tuberculosis) development needs to be done in a public forum, formalized
development process and broad participation from experts and stakeholders
representing a variety of domains
• Focus on contributing to the public domain, not an specific implementation
effort.
7
Protocol “Use Case” Priorities
1. To support CDISC Study Data Tabulation Model
(SDTM) V3.1
• Trial Design
• Planned Interventions
• Statistical Analysis Plan
-Planned Assessments
-Inclusion/Exclusion criteria
2. To support study tracking databases, e.g. EudraCT,
clinicaltrials.gov, the protocol/trial tracking aspect of trial registry
or results databases, or databases that support project
management tools.
3. To support the development of the clinical trial protocol
document
8
Protocol Representation Timeline
2005
Draft General
Clinical Trial
Registry HL7
Message
2006
Ballot General
Clinical Trial
Registry HL7
Message
Draft genCTR
BRIDG
Implementation
Modeling:
Guide
PR Element
Spreadsheet, Develop Clinical
Trial Design
Trial Eligibility
Criteria
2007
2008
2010
Additional Ballot Cycles
Draft and Ballot
ICH SCTP
HL7 Message
ANSI
Standards
Additional Ballot
Cycles
Finalize genCTR
Implementation
Guide
Draft SCTP
Implementation
Guide
Finalize SCTP
Implementation
Guide
Update CDISC
Glossary and Publish
Annually in ACT
9
What’s wrong with this picture?
Data Sources
• Site CRFs
•Laboratories
•Contract
Research
Organizations
•Development
Partners
Operational
Data
Interchange
& Archive:
ODM, LAB
Operational
Database
•Study Data
•Audit Trail
•Metadata
Submission
Data
Interchange
& Archive:
SMM
SDS, ADaM
Submission
Data
•CRT/Domain
Datasets
•Analysis
Datasets
•Metadata
10
Future of CDISC Models
Protocol
Data Sources
• Site CRFs
•Laboratories
•Contract
Research
Organizations
•Development
Partners
Operational
Operational
Database
Future
Data Uniform
Interchange
CDISC
Standard
•Study Data
& Archive:
•Audit Trail
ODM, LAB
•Metadata
Submission
Data
Interchange
& Archive:
SDTM,
SEND, ADaM
Submission
Data
•CRT/Domain
Datasets
•Analysis
Datasets
•Metadata
ODM = Operational Data Model
SDS = Submission Domain Standards
LAB = Laboratory Data Model
ADaM = Analysis Dataset Models
SEND = Std. Exchg. Non-clinical Data
Standards Protocol Representation and Terminology
11
The CDISC Roadmap
• Purpose:
– To provide a concise, common specification of all technical
products to be developed by CDISC.
• Endpoint:
– By 2008, there will be a single CDISC standard for the full lifecycle of a clinical trial or study from protocol representation
through the capture of source data to submission and archive,
comprising a set of fully integrated and consistent models which
will form logically and organically from our current set.
• Success Criteria
– All submissions to the FDA are being made using the CDISC
standard;
– The set of CDISC models in use across the full life-cycle of
clinical trials; and
– The CDISC standard being globally adopted.
12
CDISC Roadmap - Guiding Principles
•
•
Complete original mission, but focus on
harmonization of CDISC models
A single CDISC standard:
–
ODM XML defines format
•
•
–
–
Maintain Clinical Research scope while mapping to HL7
Remain platform-independent and platform-neutral
Define.xml describes common metadata
SDTM, LAB and AdaM define content
•
•
•
Standard ItemGroups and Items
Standard business rules and code lists
Metadata and information needed to support analysis
13
CDISC Roadmap – Guiding Principles
• Alignment with the BRIDG model
– HL7 as portal to healthcare
• Leverage cross-functional teams
– Fund projects not just teams, but assign teams as stewards and
maintainers
– Strive to achieve stability and maturity for current standards
• Prioritize processes over separate, individual models
• Support sites, sponsors and FDA as stakeholders.
• Expand Goals to include: Improving patient safety,
process optimization, facilitating scientific and regulatory
review.
14
CDISC Roadmap Timeline
15
CDISC Models: The View Forward
• Keep models stable so industry can catch up
– ODM, SDTM, LAB
• Support terminology team efforts to improve semantic
interoperability
• More cross-team interactions focused on harmonization
– More cross-team projects like Define.XML, Trial Design
• Complete End-2-End Traceability and SDTM/ADaM Projects
• Support the needs of existing users
– Standard maintenance, support, implementation and evolution
– Harmonmize, but maintain stable, backwards compatibility
• Support additional data uses based on CDISC standards
– Integrated summary data, ECGs, Narratives, devices, etc . . . .
• Execute the roadmap
– All submissions to the FDA use the CDISC standard;
– CDISC models in use across the full life-cycle of clinical trials
– The CDISC standard is globally adopted.
17
Data Flow Using THE
CDISC Standard
= ODM (transport)
= SDTM and Analysis Data (content)
= Protocol information (content)
= Source data
(other than SDTM/CRF data)
Protocol
Representation
Patient Info
Trial Design
(SDTM)
Analysis Plan
Clinical
(CRF or eCRF)
Trial Data
(defined by
SDTM)
Clinical Trial
Protocol
ODM
XML
(e)Source
Document
ODM
XML
Integrated
Reports
Administrative,
Tracking, Lab
Acquisition Info
CRF, Analysis
Data
Operational &
Analysis
Databases
ODM XML
Define.xml
SDTM Data,
Analysis
Data,
Metadata
Regulatory
Submissions
18
Interchange Standards:
Long-term Desired Outcomes
• A holistic approach to standards, facilitating data
interchange from sites through regulatory
submission, utilizing XML
• Standards for data acquisition supporting the
population of a cross-trial warehouse within FDA
• HL7-CDISC models harmonized to yield value for
both clinical research and healthcare – sharing of
information between EMR and clinical trials
• Global adoption of CDISC data standards
CDISC Meeting with FDA Commissioner, April 2003
19
“Neither a wise man nor a brave man
lies down on the tracks of history to
wait for the train of the future
to run over him.”
Dwight D. Eisenhower
20
The mission of CDISC is to develop and
support global,
platform-independent data standards that
enable information system
interoperability
to improve medical research and related
areas of healthcare.
21
Future of CDISC Models
Protocol
Data Sources
Operational
Operational
Future
Uniform
Database
Data
•Laboratories
CDISC
Standard
Interchange
•Contract
•Study
Data
& Archive:
Research Harmonized
with
HL7
•Audit Trail
ODM, LAB
Organizations
•Metadata
•Development
Partners
• Site CRFs
Submission
Data
Interchange
& Archive:
SDTM,
SEND, ADaM
Submission
Data
•CRT/Domain
Datasets
•Analysis
Datasets
•Metadata
ODM = Operational Data Model
SDS = Submission Domain Standards
LAB = Laboratory Data Model
ADaM = Analysis Dataset Models
SEND = Std. Exchg. Non-clinical Data
Standards Protocol Representation and Terminology
22
CDISC Teams and Projects - 2005
CDISC Technical Coordinating Committee
Single
Source
HL7-CDISC Harmonization; Domain Analysis Model
eSource
Data
Interchange
Metadata – end-to-end consistency
LAB and AE scenarios
eCRF
HL7 V3
Define.xml
Terminology (Codelists)
CV Stds
TB Stds
PRG
ODM
LAB
SDS
SEND
ADaM
OPS: Maintenance, Member Relations, Education and Implementation Groups, Glossary
23
CDISC Projects - 2005 Initiatives towards the Mission
Initiative/Project
Deliverable(s)
Status
HL7 Harmoniz
CDISC standards harmonized with the
HL7 RIM
In progress
eCRF HL7 V3
(eDCI)
V3 RIM Message representing data
collection instrument for clinical research
(eDCI)
In progress
Single Source
Proof-of-concept project to demonstrate
feasibility of collecting data once
(eSource) for multiple purposes
(healthcare and clinical research)
Proof-of-concept
done; pilots in
progress
eSource Data
Interchange
Document to describe the value and
benefits of CDISC standards (particularly
ODM) to facilitate the use of technology
for eSource data collection
Document posted for
open review and
comment
CV and TB
Standards
Standards to facilitate interactions among
sites and sponsors for specific
therapeutic areas (NIH Roadmap grants)
In progress
24
Interchange vs Interoperability
Syntax  Structure
• Main Entry: in·ter·op·er·a·bil·i·ty
Semantics  Meaning
: ability of a system ... to use the parts or equipment of another system
Source: Merriam-Webster web site
• interoperability
: ability of two or more systems or components to
exchange information and to predictably use the information that has been
exchanged.
•
Source: IEEE Standard Computer Dictionary: A Compilation of
IEEE Standard Computer Glossaries, IEEE, 1990]
Syntactic
interoperability
(interchange)
Semantic
interoperability
Source: Charles Mead, MD, HL7
25
HL7 Reference Information Model (RIM)
HEALTH LEVEL 7
REFERENCE INFORMATION MODEL
RIM_0088
released January, 1999
reflects agreements made through harmonization in November, 1998
Healthc
Healthc
are_finances
are_finances
Mas ter_tables
Healthc are_finances
HealtHealthc
hcare_stak
are_finances
eholders
Patient_encount
Healthc are_finances
ers
has_as_participant
Financi al_transaction
alternat e_desc
is_c ategorized_by 0. .* desc
extended_amt
is_associated_with 0. .* fee_schedule_cd
insurance_amt
post ing_dt
qty
transact ion_batch_id
is_entered_by t ransaction_cd
0. .* transact ion_dt
transact ion_id
t ransaction_t ype_cd
is_associated_with unit_amt
0. .* unit_cos t_amt
is_the_purc haser_of 1
Authentication
aut henticat ion_dt
t ype_cd
0. .* is_related_to
1 Cli nical _document_header
aut henticat ion_dt
availability_stat us_cd
change_reason_cd
complet ion_stat us_cd
confident iality_stat us_cd
content _present ation_cd
doc ument_header_c reat ion_dt
file_nm
id
has_been_originat ed_by 0. .* last_edit _dt
originat ion_dt
reporting_priority_cd
results _report _dtt m
storage_stat us_cd
has_been_received_by 0. .* transcript ion_dt
t ype_cd
is_t ransc ribed_by 0. .*
0. .*
is_related_to
0. .*
is_related_to
is_related_to
1
Heal th_benefit_plan_purchaser
is_a 0. .1
0. .1
is_a_role_of
Origi nator
0. .1
of
is_a 0. .1
Stakeholder_identifier
effect ive_dt
is_is sued_by id
0. .* ident ifier_t ype_cd
issued_dt
qualifying_information_t xt
terminat ion_dt
Docum ent_recipient 0. .1 of
0. .1 is_a
0. .*
is_ass igned_to
Stakeholder_affiliation
affiliation_t ype_cd
desc
effect ive_dt
terminat ion_dt
1
0. .*
0. .* documents
P ati ent_information_discl osure
disclosure_dtt m
info_dis clos ed_desc
info_request ed_desc
reason_cd
requested_dtt m
urgency_cd
0. .1
0. .*
is_parent_doc ument_for
is_provided_to
pert ains_to
0. .*
has_as _a_parent_document
0. .1
is_identified_as
1
is_a_role_of
0. .1
0. .1
1
takes_on_role_of 1
is_a_c ontac t_for
0. .*
is_a_c ontac t_for 0. .* Contact_person 0. .* is_a_c ontac t_for
contact _reason_cd 1
participates _in
is_a_c ontac t_for 0. .*
0. .1 is_a_role_of
Heal th_chart_defi ciency
assessment _dt
desc
level_cd
t ype_cd
0. .1
is_the_s ource_of
is_a_role_of 0. .1
Guarantor
financial_class_cd
has_as_a_cont act household_annual_income_amt guarantees_
payment_under
0. .1 household_size_qty
issues
1
1
0. .1 is_a_role_of
0. .* is_is sued_by
is_a_c ontac t_for 1. .* I nsurance_certification_contact 0. .1
participation_t ype_cd
is_a_role_of
1 has_as_a_cont act
Person_em ployment
addr
0. .* effect ive_dt
hazard_exposure_t xt
job_class_cd
job_t it le_nm
phon
prot ective_equipment_t xt
s alary_amt
s alary_t ype_cd
stat us_cd
terminat ion_dt
occupation_cd
job_stat us_cd
is_employee_in 1
is_a_role_of
0. .1
has_payment_
guarant eed_by
contains 1
Medicare_coverage
effect ive_dt
eligibility_cd
id
lifet ime_res_delay_day _qty
lifet ime_reserve_day _qty
medic are_c overage_t ype_cd
program_t ype_cd
renal_cd
terminat ion_dt
Pati ent_slot
1
has_an_assessment _of
Patient_service_location_slot
0. .*
is_a_scheduleable_unit_for
0. .*
is_a_scheduleable_unit_for
0. .*
is_a_scheduleable_unit_for
0. .*
is_a_scheduleable_unit_for
0. .*
P erson
birth_dtt m
1 has
birthplace_addr
citizenship_c ountry_cd
Notary_publ ic
confidentiality_constraint_cd
effect ive_dt
deceased_dtt m
notary_county_cd
deceased_ind
not ary _state_cd
disability_cd
terminat ion_dt
educ ation_level_cd
takes_on_role_of 1 ethnic_group_cd
gender_cd
0. .1 is_a_role_of
language_cd
marit al_stat us_cd
1 takes_on_role_of
ent ers 1 military_branch_of_service_cd
milit ary _rank _nm
milit ary_stat us_cd
nationality_cd
primary_name_represent ation_cd 1 takes_on_role_of
primary_name_t ype_cd
takes_on_role_of 1 primary _nm
Bil li ng_inform ati on_item
condition_cd
race_cd
occurrence_cd
religious_affiliation_cd
occurrenc e_dt
s tudent_cd
occurrence_span_cd
very_important _person_cd
occurrence_span_from_dt
occurrenc e_span_thru_dt
quant ity_amt
takes_on_role_of 1
quant ity_t ype_cd
value_amt
value_cd
0. .*
Medicai d_coverage
aid_category_cd
S chedule
id
Durabl e_medi cal_equipm ent_slot
I ndividual _healthcare_practi ti oner_slot
contains
1. .*
Master_numeri c_range
range_t ype_cd
condition_desc
high_range_amt
high_ges tat ion_age_amt
high_value_amt
low_age_amt
low_ges tat ion_age_amt
low_value_amt
race_s ubspecies_t xt
sex_t xt
species_t xt
Champus_coverage
handicapped_program_cd
non_avail_cert_on_file_ind
retirement _dt
s tat ion_id
Healthcare_servi ce_provider
board_cert ific ation_t ype_cd
board_certified_ind
certificat ion_dt
effect ive_dt
license_id
1 part icipat es_as
participates _in 1
recertificat ion_dt
specialty_cd
terminat ion_dt
provides_patient_services_at
1. .*
is_a_role_of 0. .1
Heal thcare_provider_organization
0. .1ains_to
pert
1 has
Patient
ambulat ory_stat us_cd
has 1
birth_order_amt
is_s cheduled_by
living_arrangement_cd 1
has_as_ 0. .1 living_dependency_cd 1 is_request ed_by
a_cont act
multiple_birth_ind
newborn_baby_ind
organ_donor_ind
has
1 preferred_pharmacy _id
0. .1 is _target _of
is_a_role_of 0. .1
0. .* applies_to
0. .1 is_the_primary_provider_for
is_s cheduled_by
1
part icipat es_as
1
1. .* belongs_to
is_request ed_by
1
Active_parti cipation
begin_dtt m
end_dtt m
duration_t m
participation_t ype_cd
has 1
1
has_as_target
0. .*
Episode
desc
episode_t ype_cd
id
lis t_closed_ind
outcome_t xt
0. .1 s pecfies
recurring_s ervice_ind
has
0. .* is_is sued_by
Preauthorization
authorized_encounters_amt
authorized_period_begin_dt
aut horized_period_end_dt
id
issued_dtt m
requested_dtt m
aut
0. .1horizes
restriction_desc
stat us_cd
st atus_change_dtt m
Admi nistrative_pati ent_accident
accident_death_ind
accident _desc
accident _dtt m
is_obtained_from 0. .* accident_location_desc
accident _state_cd
acc ident_t ype_cd
job_related_accident_ind
pert ains_to
assessment _dtt m
0. .*
Target_parti
begin_dtt m
has_as_target 0. .* end_dtt m
is_authorized_by
has_parts
1
has 1. .*
involves 0. .*
Pati ent_departure
act ual_dis charge_disposition_cd
disc harge_dtt m
discharge_locat ion_id
expect ed_discharge_disp_cd
P ati ent_admission
admis sion_dtt m
admission_reason_cd
admission_referral_cd
admission_source_cd
admission_t ype_cd
patient_valuables_desc
pre_admit_t est_ind
readmiss ion_ind
valuables_location_desc
preceded
0. .1
t erminates
1
has_parts
1
0. .*
is_assigned 1
has
I npati ent_encounter
ac tual_days _qty
est imat ed_days _qty
1. .*
is_part _of
0. .1 follows
0. .1
has_assigned_to_it
1
has
pert ains_to 0. .*
Ri sk_m anagement_incident
inc ident_cd
incident _dtt m
incident_severity_cd
inc ident_t ype_cd
1. .*is_s cheduled_by
1 is _prec eded_by
1 has_as_participant
0. .*
precedes
0. .1 precedes
Patient_arri val
acuity_level_cd
arrival_dtt m
arrival_t ype_cd
medical_service_id
source_of_arrival_cd
mode_cd
Appointment
reserves 0. .* appointment _disposition_cd
appoint ment_durat ion_qty
appointment _reason_cd
are_booked_in 0. .* appoint ment_request _reason_cd
appoint ment_t iming_tq
involves 1
appoint ment_t ype_cd
cancellat ion_dtt m
c ancellation_reason_cd
est imated_duration_amt
event _reason_cd
schedules 0. .* expect ed_end_dtt m
ex pected_service_desc
ex pected_start _dtt m
id
occurence_id
overbook_ind
scheduling_begin_dtt m
scheduling_completed_dtt m
scheduling_stat us_cd
stat us_cd
urgency_cd
visit_t ype_cd
wait _list _priority_amt
1. .* pert ains_to
1 is_s cheduled_by
1
pert ains_to
has
1. .* belongs_to
1 is_request ed_by
1 is_entry _loc ation_for
0. .1 is_t arget_for
0. .1 is _loc ation_for
contains 0. .*
Patient_service_l ocation_group
id
Location_encounter_role
accommodation_cd
effective_dtt m
locat ion_role_cd
stat us_cd
0. .*
terminat ion_dtt m
t rans fer_reason_cd
transfer_reas on_desc
usage_approved_ind
0. .*
0. .*
is_billed_to
cipation
1. .* is _target _of
Treatment_intent_or_order
dosage_t xt
earlies t_dispens e_dt
Indic ation_cd
non_form_aut horized_ind
0. .* fulfills
providers_treatment _ins truction_t xt
Servi ce_event
rejection_reason_cd
0. .1 at tes tat ion_dtt m
reques ted_give_rate_amt
attest ation_due_dt
1
requested_give_st rength_amt
delivers 0. .* begin_dtt m
subs titut ion_allowed_ind
is_associated_with 1 charge_t o_practice_amt is_t arget_for
supplier_special_dispens ing_instruction_cd
is_document ed_by 0. .* charge_t o_practice_cd
0. .* has_as_target
verific ation_required_ind
pat ient_sensit ivity_cd
S ervi ce_event_rel ati onship
is_c harged_to 0. .* consent_cd
relationship_t ype_cd
declined_ind
service_desc
0. .* has_as_source
end_dtt m
is_ass igned_to 0. .* filler_id
1
is_performed_at 0. .* filler_order_stat us_cd
is_reason_for
is_source_for
filler_order_st atus _dtt m
0. .*
recurring_service_cd
Servi ce_reason
scheduled_start _dtt m
is_evidence_for
0. .* determinat ion_dtt m
s ervice_event _desc
0. .1
has_as _evidence doc umentat ion_dtt m
specimen_received_dtt m
reason_t xt
specimen_action_cd
nm
family_awareness_t xt
has_as_reason
0. .*
individual_awareness_cd 0. .1
is_reason_for
confidential_ind
has_as_target 0. .1
P ati ent_encounter
adminis trative_outcome_t xt
c ancellation_reason_cd
desc
encount er_c lass ific ation_cd
end_dtt m
expec ted_insurance_plan_qty
first _similar_illnes s_dt
follow_up_t ype_cd
id
patient_c lass ific ation_cd
purpose_cd
record_signing_dtt m
special_courtesies_cd
start _dtt m
stat us_cd
transport_requirement_cd
urgency_cd
t riage_c lass ific ation_cd
medical_service_cd
confidentiality_constraint_cd
1
1
1
is_source_for
Dietary_intent_or_order
diet_t ype_cd
dietary_inst ruction_desc
dietary_tray_t ype_cd
service_period_cd
service_t ype_cd
Observation_intent_or_order
patient _hazard_cd
reason_for_st udy_cd
relevant _clinical_information_t xt
reporting_priority_cd
specimen_action_cd
Referral
authorized_visits _qty
desc
reason_t xt
0. .* orders
has_as_act ive_participant
is _terminat ed_by
1
is_an_ins tance_of
is_t arget_for
Service_intent_or_order
charge_t ype_cd
1 clarification_phon
end_condition_cd
entering_device_cd
escort_required_ind
expec ted_performance_time_qty
filler_order_id
filler_t xt
order_cont rol_cd
order_cont rol_reason_cd
Master_calculated_observation
order_effective_dtt m
derivation_rule_desc
order_group_id
order_id
order_placed_dtt m
order_quant ityt iming_qt
placer_order_id
plac er_t xt
planned_patient_transport_cd
report _results_t o_phon
response_request ed_cd
service_body _site_cd
service_body_site_modifier_cd
has_as_participant
0. .1
service_body_source_cd
t arget_of_service_cd
transport _arranged_ind
may_be_referred_to_in 0. .1
transport_arrangement_responsibility_cd
is_ent ered_at 0. .* t ransport_mode_cd
when_to_c harge_dtt m
has_as_target 0. .1 when_t o_charge_t xt
is_fulfilled_by
0. .1 results_stat us_cd
intent _or_order_cd
has_as_reason 0. .1 join_cd
is _target _of 0. .*
1. .*
0. .* has_as_source
duration_t m
has_as_target 0. .* participation_t ype_cd
0. .* is_present _in
is _prec eded_by
Master_pati ent_servi ce_location
is_primary _fac ility_for addr
0. .1 closing_dt
desc
houses 1 email_address
provides_services_on_behalf_of id
licensed_bed_qty
0. .* nm
opening_dt
phon
is_included_in 0. .* s ervice_specialty_cd
slot_size_inc rement _qty
stat us_cd
t ype_cd
equipment_t ype_cd
includes 0. .1
Master_categorical _observation
abnormal_result_cd
allowed_value_t ype_cd
critical_result_cd
normal_result_cd
preferred_coding_s ystem_cd
valid_ans wer_cd
0. .* participates _in
is_source_for 0. .1
is_ass igned_to
Master_continuous_observation
c orresponding_SI_unit_of_measure_cd
cust omary_unit _of_measure
delta_c heck_numeric_change_computat ion_met hod_t xt
delt a_check_numeric_change_threshold_amt
delta_check_numeric_high_value_amt
delt a_check_numeric_low_value_amt
delt a_check_numeric_retention_days _qty
length_and_decimal_precision_amt
minimum_meaningful_increment_amt
si_conversion_fact or_t xt
0. .* participates _in
participates _in 1
1 has
collec tion_volume_amt
condition_cd
handling_cd
id
0. .1 is _target _of
method_of_collection_desc
number_of_sample_containers _qty 0. .* is_collected_during
s pecimen_additive_t xt
specimen_danger_cd
specimen_source_cd
t ransport_logistics_cd
0. .1
has_as_participant
0. .*
has 1
0. .* pert ains_to
conforms_to
1
Appoi ntm ent_contact_person participates _in
role_cd
0. .*
0. .* is_part _of
is_involved_in
Patient_bil li ng_account
1
has_as_primary_facility 0. .*
ac count _id
adjust ment_cd
0. .* has_a_primary_provider
authorization_information_t xt
billing_stat us_cd
1 has
cert ific ation_required_ind
current_unpaid_balance_amt
delet e_dt
Disabi li ty
1 deleted_account _reason_cd
has
effect ive_dt
pert ains_to return_t o_work_aut h_dt
has_pay ment_guarant eed_by 0. .* expec ted_insurance_plan_qty
expect ed_payment _source_cd
terminat ion_dt
0. .*
notice_of_admission_dt
unable_to_work_effect ive_dt
0. .* belongs_to
notice_of_admiss ion_ind
patient _financial_class_cd
price_schedule_id
0. .1
purge_stat us_cd
has_charges_for
purge_st atus_dt
report_of_eligibilit y_dt
0. .1
Diagnostic_related_group
ret ent ion_ind
bas e_rate_amt
is_billed_from
signature_on_file_dt
is_assigned_as
c apital_reimburs ement_amt
special_program_cd
cost _weight_amt
1
s toploss_limit_ind
id
0.
.1
sus pend_charges_ind
major_diagnostic_category_cd
is_ass igned_to
t otal_adjust ment_amt
has_as_a_prior_acc ount
operat ing_reimburs ement_amt
total_charge_amt
0. .*
reimburs ement_amt
t otal_payment_amt
0. .* is_an_assignment _of
Bad_debt_bil li ng_account
standard_day _qty
separate_bill_ind
bad_debt_recovery_amt
st andard_total_charge_amt
Encounter_drg
bad_debt_transfer_amt
approval_ind
trim_high_day _qty
transfer_to_bad_debt _dt
assigned_dtt m
t rim_low_day _qty
0. .1
t ransfer_to_bad_debt _reason_cd
confidential_ind
is_the_prior_account_for
c ost_outlier_amt
desc
grouper_review_cd
is_assigned_by
grouper_version_id
0. .* outlier_days _qty
out lier_reimburs ement_amt
Collected_speci men_sample
body _site_cd
outlier_t ype_cd
is_collect ed_by c ollect ion_body_site_modifier_cd
collection_end_dtt m
0. .*
collection_method_modifier_cd
collection_scheduled_dtt m
0. .* is_sourced_from
collect ion_start _dtt m
is_a_role_of
Indi vidual _healthcare_practitioner
desc
fellowship_field_cd
graduate_sc hool_nm
provides 1 graduat ion_dt
position_cd
practit ioner_t ype_cd
primary_care_ind
res idency_field_cd
slot_size_inc rement _qty
Administrative_patient_death
death_cert ificate_id
deat h_certificat e_recorded_dt
death_c lass ific ation_cd
death_dtt m
death_locat ion_nm
deat h_not ification_s ource_nm
death_verific ation_cd
death_verificat ion_dt
deat h_verificat ion_nm
has_as_target
0. .*
0. .1
0. .*
Administrative_bi rth_event
pert ains_to baby_detained_ind
0. .1 birth_cert ificate_id
birth_met hod_cd
birt h_recorded_county_cd
birt h_recorded_dt
newborn_days _qty
st illborn_ind
Servi ce_intent_or_order_rel ati onship
relationship_t ype_cd
reflex_test ing_trigger_rules_desc
constraint_t xt
quant ityt iming_qt
is_ordered_on
Master_treatment_service
dea_level_cd
drug_category_cd
formulary_stat us_cd
medic ation_form_cd
pharmac eutical_class_cd
route_cd
therapeutic_class_cd
Master_observation_service
inst rument _id
has 1 permitt ed_data_t ype_cd
proces sing_time_qty
is_basis_for 0. .* spec imen_required_ind
typical_t urnaround_time_qty
is_assessed_against
0. .*
is_offered_by 0. .*
has_as_purchaser
1
is_s cheduled_by
1 has
Guarantor_contract
1. .* billing_hold_ind
billing_media_cd
has_coverage_affirmed_by 1 charge_adjust ment_cd
contract _duration_cd
cont rac t_t ype_cd
effect ive_dt
1 is_validat ed_by
interest _rate_amt
has_parts Heal thcare_benefi t_product
periodic_payment_amt
assignment_of_benefits_ind
priority_ranking_cd
1 benefit_product _desc
terminat ion_dt
0. .*
is_part _of 0. .*
id
benefit_plan_nm
provides_payment_guarant ee_for
Healthcare_benefit_coverage
includes 1
annual_limit_amt
benefit_plan_t ype_cd
benefit _desc
benefits_coordinat ion_ind
0. .* provides_opinion_on
is_a_role_of 0. .1
benefit _product _nm
c ob_priority_amt
Bad_debt_collection_agency 1 is_assigned
Certi fi cati on_second_opinion
has_parts dependent _coverage_ind
combine_baby_bill_ind
effect ive_dt
dependent_coverage_limit_amt
effect ive_dt
0. .1 is_associated_with
stat us_cd
1
effective_dtt m
eligibilit y_source_cd
lifet ime_limit_amt
group_benefit_ind
0. .* is_provided_by
terminat ion_dtt m
mail_c laim_party_cd
Preferred_provider_parti cipation
is_part _of
role_cd
agreement_t ype_cd
policy_source_cd
0. .*
baby_coverage_ind
release_information_cd
is_governed_by effect ive_dt
0. .1 governs
Healthcare_benefit_service
terminat ion_dt
blood_deduct ible_amt
stat us_cd
access_prot ocol_desc
0. .*
copay_limit_ind
terminat ion_dt
c apitat ion_ind
daily_deduct ible_amt
coinsurance_ind
0. .*
non_c overed_insurance_cd
0. .*
coinsurance_pct
has_as_care_provider
policy_amount _class_cd
copayment_amt
has_as_care_recipient
policy_amt
deduct ible_amt
policy_category_cd
lower_coverage_limit_amt
policy_deduct ible_amt
pay_cap_limit_amt
policy_limit_day _qty
pcp_referral_ind
policy_s cope_cd
primary_care_provider_ind
room_coverage_type_amount_cd
0. .* is_for
review_ind
upper_coverage_limit_amt
0. .* provides_c overage_for
Durabl e_medi cal_equipment_group
id
0. .*
requests
Master_service
allowable_proc essing_priority_cd
is _produced_by 0. .1 allowable_reporting_priority_cd
billing_reference_t xt
challenge_information_t xt
is_request ed_by 1 confidentiality_cd
effect ive_dt
fact ors_t hat _may _affect _observation_desc
fee_amt
fixed_canned_mes sage_cd
is_target 1
imaging_measurement_modality_cd
incompatible_change_dtt m
has_target 0. .*
instrument_identifier_coding_syst em_nm
Master_servi ce_rel ati onship
instrument_identifier_nm
relationship_t ype_cd
int erpret ation_considerat ions_desc
reflex_test ing_trigger_rules_desc
kind_of_quantity_observed_cd
constraint_t xt
last_update_dtt m
quant ityt iming_qt
1. .* is_covered_by
met hod_cd
method_desc
nature_of_service_cd
has_source 0. .*
is_source 1 observation_id_suffix_t xt
orderable_s ervice_ind
patient _preparation_desc
point_versus_interval_cd
is_delivered_during 1 port able_device_ind
preferred_ordering_met hod_t xt
preferred_scheduling_met hod_t xt
1 is_inst ant iat ed_as
procedure_medic ation_cd
report _display_order_t xt
required_credentials_desc
servic e_alternate_id
service_alt ernate_identifier_coding_syst em_nm
service_alternate_identifier_nm
service_alternate_name_use_cd
servic e_alternate_nm
Master_speci men_requirement
additive_cd
service_c ontraindic ation_cd
c ontainer_desc
service_desc
container_preparation_desc
service_performance_schedule_cd
container_volume_amt
service_primary _nm
derived_spec imen_cd
service_requirement _desc
minimum_collec tion_volume_amt
service_t ype_cd
normal_collec tion_volume_amt
s tandard_t ime_t o_perform_dtt m
special_handling_desc
t arget_anatomic _site_cd
spec imen_priorities_cd
t arget_of_service_cd
specimen_retention_t ime_amt
universal_service_id
spec imen_t ype_cd
univers al_s ervice_identifier_coding_syst em_nm
univers al_s ervice_identifier_nm
quant ityt iming_qt
is_s pecified_for 0. .*
join_cd
has_as_basis
Em ployee
Insurance_certification
appeal_reason_cd
cert ific ation_day _qty
effect ive_dt
id
insurance_verificat ion_dtt m 0. .* affirms_insurance_c overage_for
modificat ion_dtt m
non_concur_cd
0. .* provides _validation_for
non_conc ur_effective_dtt m
penalty_amt
terminat ion_dt
report_of_eligibilit y_dt
report _of_eligibility_ind
0. .* contains
is_request ed_by 0. .1
involves
has_as_employee 0. .*
1 issues
1
offers
0. .*
may _act_in_
t he_role_of
has_as_
employer
Insurer
effect ive_dt
terminat ion_dt
1
Durable_m edical _equipment
id
slot_size_inc rement _qty
belongs_to 1. .*
t ype_cd
is_a_s ubdivision_of
1
0. .1
0. .*
may_request
0. .*
requests
produces
0. .*
0. .1
has _as_a_subdivis ion
0. .* is_a_c ontac t_for
has_as_a
_cont act
0. .*
may_request
is_request ed_by
Resource_slot
offset _qty
quant ity_amt
resource_t ype_cd
slot _state_cd
start _dtt m
0. .*is_reserved_by
0. .*is _managed_by
is_a_role_of 0. .1
Accident_inform ati on_source
0. .1 cat egorizes
Organization
organization_name_t ype_cd 1 takes_on_role_of
organizat ion_nm
1 assigns
standard_industry_class_cd 1 takes_on_role_of
0. .*
requests
I ndivi dual_healthcare_practi ti oner_group
id
0. .* is_for
Employer
effect ive_dt
0. .1 is_a_role_of
has_as_a_cont act terminat ion_dt
1 is_employer_of
0. .1
Pati ent_service_location_request
t ype_cd
0. .*
requests
0. .*
may_request
is_request ed_by
0. .1
is_the_recipient _of
P ati ent_information_recipient
Heal th_chart
health_chart _id
0. .* belongs_to
health_chart_t ype_cd
contains 0. .1 stat us_cd
0. .* is_housed_at
Pati ent_appoi ntm ent_request
Durabl e_m edical _equipm ent_request
quant ity_amt
t ype_cd
Indi vidual _healthcare_practi ti oner_request
practit ioner_t ype_cd
contains
is_used_by
0. .*
Person_alternate_name
effect ive_dt
cd
nm
reason_cd
terminat ion_dt
t ype_cd
S takeholder_affiliate
family_relationship_cd is_a_role_of
takes_on_
role_of
Resource_request
allowable_substitutions_cd
durat ion_qty
start _dtt m
is_request ed_by 0. .* start_offset _qty
stat us_cd
Appoi ntm ent_request
appointment_rqst _reason_cd
1 requests
appointment _rqs t_t ype_cd
equip_select ion_criteria_pv
id
location_select ion_criteria_pv
occurence_id
1 requests
priority_cd
repeating_interval_durat ion_qty
requested_ri
requests
is_request ed_by
rqst_event _reason_cd
1. .*
0. .*
rqsted_durat ion_qty
st art _dt
Servi ce_schedul ing_request
allowable_substitutions_cd
t ime_select ion_criteria_pv
durat ion_qty
start _dtt m
start_offset _qty
stat us_cd
Transcriptioni st
1 takes_on_role_of
Stakeholder
addr
1 takes_on_role_of
is_assigned 1 credit_rating_cd
email_address_t xt 1 may_act _as_a
is_a_role_of 0. .1
1 takes_on_role_of
takes_on_role_of 1 phon
t ype_cd
1 takes_on_role_of
participates_as_primary _in 1
0. .* has_as_primary_participant
0. .1 participates _in
takes_on_role_of 1
0. .* refers_t o_person_by
takes_on_role_of 1
1 collects
takes_on_role_of 1
takes_on_role_of
1
0. .*
has_as_secondary_participant
participates _as_secondary _in
is_related_to
0. .*
may_be_contained_in
transcribes
0. .1
issues 1
Identifier_issuing_authori ty
effect ive_dt
terminat ion_dt
Producer_of_m aster_service
service_producing_depart ment_t ype_cd 0. .*
0. .* pert ains_to
Heal thcare_document_authenticator
has_as_a_cont act 0. .1
0. .*
is_associated_with
1. .*
Consent
Advance_di rective
competence_ind
directive_cd
disclosure_level_cd
life_qualit y_desc
mortuary_preference_nm
not arizat ion_dt
assessment _dtt m
employment_related_ind
Encounter_practitioner
participation_t ype_cd
Care_event
Procedure
anesthesia_cd
anes thesia_minutes _qty
delay_reason_t xt
inc ision_closed_dtt m
incision_open_dtt m
priority_amt
procedure_cd
proc edure_dtt m
procedure_functional_t ype_cd
procedure_minute_qty
modifier_cd
Treatm ent_servi ce_event
prescript ion_id
refills_remaining_qty
notes_t xt
PTrout
PTc omp
indic ation_cd
expirat ion_dtt m
subst ance_lot_number_t xt
subst ance_manufact urer_cd
collects 0. .1
0. .*
is_part ic ipant_for
0. .1 is_request ed_by
Treatment_service_dispense
dispense_package_met hod_cd
dispense_pack age_size_amt
needs_human_review_ind
rejec tion_reason_t xt
s ubstit ution_cd
suppliers_special_dispens ing_instruction_cd
total_daily_dose_amt
Treatm ent_servi ce_give
administ ration_desc
give_per_time_unit_cd
give_quant ityt iming_qt
give_rate_amt
max_give_amt
min_give_amt
needs_human_review_ind
subst itut ion_stat us_cd
supplier_special_administrat ion_instruction_cd
Treatm ent_servi ce_admi nistration
administered_rate_t xt
complet ion_stat us_cd
substance_refusal_reason_cd
s ubstit ution_cd
s ystem_entry _dtt m
Treatment_intent_or_order_revi sion
dispense_package_met hod_cd
is_part _of 1. .* dispense_pack age_size_amt
give_indic ation_cd
give_per_time_unit_cd
give_rate_amt
las t_refilled_dtt m
max_give_amt
min_give_amt
needs_human_review_ind
order_revision_PTc omp
order_revision_PTrout
order_revision_quant ityt iming_qt
ordered_administration_met hod_cd
prescript ion_id
providers _administrat ion_instruction_cd
refills_allowed_qty
refills_dos es_dispensed_qty
refills_remaining_qty
subst itut ion_stat us_cd
suppliers_dispens ing_instruction_cd
total_daily_dose_amt
total_daily_dose_cd
1 has_parts
Assessment
Clinical _observation
abnormal_result_ind
las t_observed_normal_values _dtt m
nat ure_of_abnormal_testing_cd
clinically_relevant_begin_dtt m
clinically_relevant_end_dtt m
observation_met hod_cd
observat ion_stat us_cd
observation_st atus _dtt m
obs ervation_sub_id
observat ion_value_t xt
probability_amt
references_range_t xt
universal_servic e_identifier_suffix_t xt
user_defined_access_check_t xt
value_t ype_cd
value_units_cd
Goal
action_cd
act ion_dtt m
c lass ific ation_cd
current _review_stat us_cd
current_review_st atus _dtt m
episode_of_care_id
est ablished_dtt m
evaluation_cd
evaluation_comment_t xt
expected_achievement _dtt m
goal_list _priority_amt
life_c ycle_dtt m
life_cy cle_stat us_cd
management _discipline_cd
next _review_dtt m
previous_review_dtt m
review_interval_cd
t arget_t xt
t arget_t ype_cd
goal_cd
Heal th_issue
diagnosis_cd
onset _dtt m
billing_priority_amt
severity_cd
c lass ific ation_cd
confirmat ion_stat us_cd
persist ence_cd
probability_amt
probability_t xt
prognosis_desc
prognosis_awareness_desc
cd
Allergy
allergen_id
allergy_cd
allergy_reaction_cd
allergy _reac tion_desc ription_t xt
allergy_severity_cd
allergy_t ype_cd
assessment _dtt m
employment_related_ind
Condition_node
act ual_resolut ion_dtt m
estimated_resolut ion_dtt m
life_cycle_st atus _dtt m
lifecy cle_stat us_cd
management _discipline_cd
ons et_t ime_t xt
onset _dtt m
ranking_amt
employment_related_ind
0. .* specified_in
26
The BRIDG Model
(a.k.a. PSM, DSAM, DAM)
•
Vision: Create a domain analysis model for the clinical research domain to
harmonize clinical research standards among each other and to harmonize
standards between clinical research and healthcare
•
A Key Goal: Define a structured computable protocol representation that
supports the entire life-cycle of clinical trials protocol to achieve syntactic and
semantic interoperability
•
Milestones:
– January 2004 - Initiated by CDISC Board, with HL7 RIM expertise and leadership
from Dr. Charlie Mead; followed HL7 Development Framework (HDF)
– Contributions of resources from NCI, HL7 RCRIM, FDA, CDISC, NIH and
others collaborated to create the Biomedical Research Integrated Domain Group
(BRIDG) model
– January 2005 – Adopted by HL7 RCRIM as Clinical Research Domain Analysis
Model and posted on open source website
– February 2005 – CDISC ODM mapped to HL7 RIM (collaborative effort among
CDISC, NCI, HL7)
27
Mapping ODM to the RIM
Sally Cassells, ODM Team Leader
28
CDISC and HL7:
Why BRIDG?
Level of Abstraction
Domain Anaysis Model or Problem Space Model (a la HDF)
RIM
ODM
29
CDISC Standards Harmonization
Protocol
Data Sources
Operational Submission
Operational
Data
Database
Data
•Laboratories
Harmonizing to THE CDISCInterchange
Standard
Interchange
•Contract BRIDG:
& Archive:
•Study Data
& Archive:
Research
SDS, ADaM
•Audit Trail
ODM, LAB
Organizations
SEND
•Metadata
•Development
Partners
• Site CRFs
Submission
Data
•CRT/Domain
Datasets
•Analysis
Datasets
•Metadata
ODM = Operational Data Model/Std
SDS = Submission Domain Standards
LAB = Laboratory Data Model/Std
ADaM = Analysis Data Models
SEND = Standards for the Exchange of Non-Clinical Data
30
CDISC Roadmap Timeline
31
Early BRIDG Implementations
and Use Cases
• NCI-CDISC: eData Collection Instrument (eDCI)
Message Development
• CDISC-HL7 Protocol Representation Group: Trial
Tracking and Registries
• NCI-CDISC: Clinical Trials Object Model (CTOM), a
reference implementation of BRIDG to support
collaborative research
• FDA-NCI: CRIX Clinical Data Repository based on
Janus, populated with SDTM data, with data accessible
via BRIDG
• caMATCH: Matching subjects to protocols – in
implementation
32
cd Comprehensiv e Logical Model
Design Concepts::Masking
Clinical Trial Design
+
+
+
+
level:
objectOfMasking (set):
procedureToBreak:
unmaskTriggerEvent (set):
Protocol
Concepts::
Control
HasSubElements
AbstractActivity
«Period»
Design Concepts::Element
Protocol Concepts::DesignCharacteristic
Name:
Author:
Version:
Created:
Updated:
Comprehensive Logical Model
Fridsma
1.0
7/22/2005 2:53:51 PM
7/29/2005 2:33:32 PM
+
+
+
+
+
+
Protocol
Concepts::
Scope
Protocol Authoring
and Documentation
-
Protocol
Concepts::
Configuration
synopsis:
type: test value domain = a,d,f,g
summaryDescription:
summaryCode:
detailedMethodDescription:
detailedMethodCode:
Children: Set
epochType: EpochTypes
AbstractActivity
displayName: char[]
whoPerforms: int
sequence: int
procDefID: PSMCodedConcept
sourceText: char[]
SubjectEvent
Protocol Concepts::StudyBackground(w hy)
+
+
+
+
+
+
+
+
+
+
+
hasElements
hasScheduledEvents
Design Concepts::PlannedTask
-
Protocol
Concepts::Bias
Design Concepts::Arm
Design Concepts::ProtocolEv ent
description: PSMDescription
summaryOfPreviousFindings: PSMDescription
summaryOfRisksAndBenefits: PSMDescription
justificationOfObjectives: PSMDescription
justificationOfApproach: PSMDescription
populationDescription: PSMDescription
rationaleForEndpoints: PSMDescription
rationaleForDesign: PSMDescription
rationaleForMasking: PSMDescription
rationaleForControl: PSMDescription
rationaleForAnalysisApproach: PSMDescription
hasElements
Protocol Concepts::StudyObligation
+
+
+
+
1
type: ENUMERATED
description: PSMDescription
commissioningParty:
responsibleParty:
Design Concepts::
Randomization
+
+
Protocol Concepts::
Concurrency
-
-
parent: AbstractActivity
eventType: ScheduledEventType
studyOffset: PSMInterval
studyDayOrTime: char
nameOfArm: char[]
plannedEnrollmentPerArm: char[]
randomizationWeightForArn: int
associatedSchedules: Set
tasksPerformedThisSchedule
taskAtEvent
hasOngoingEvents
minimumBlockSize:
maximumBlockSize:
1..*
AbstractActivity
+correlativeStudy 0..*
Design Concepts::Ev entTask
BusinessObj ects::Study
BusinessObj ects::
ClinicalDev elopmentPlan
-_DevelopmentPlan
+
+
+
+
+
+
BusinessObj ects:
:Amendment
*
-
+primaryStudy 1
startDate: Date
endDate: Date
type: PSMCodedConcept
phase: PSMCodedConcept
randomizedIndicator: Text
SubjectType: PSMCodedConcept
localFacilityType: LocalFacilityType
centralFacilitityType: CentralFacilitiyType
eventID: OID
taskID: OID
purposes: Set
-
Protocol Concepts::StudyObj ectiv e(w hat)
+
+
+
+
1
+
description: PSMDescription
intentCode: SET ENUMERATED
objectiveType: ENUM{Primary,Secondary,Ancillary}
id: PSMID
+
+
+
+
+
+
+
+
+
+
+
+
1
1..* -
BusinessObj ects::
ClinicalStudyReport
description: BRIDGDescription
ranking: OutcomeRank
associatedObjective: Set
analyticMethods: Set
asMeasuredBy: Set
outcomeVariable:
threshold:
-
Design Concepts::Ev entTaskPurpose
BasicTypes::StudyDatum
isBaseline: boolean
purposeType: PurposeType
associatedOutcome:
-
type:
+target 0..*
complete: bool
value: Value
timestamp: timestamp
itemOID:
Defined By
+
+
+
+
-
«ODM:ItemData»
Design Concepts::
SubjectDatum
-
«ODM ItemData»
Design Concepts::
DiagnosticImage
BasicTypes::RIMActiv ityRelationship
BasicTypes::StudyVariable
-
«ODM:ItemData»
Design Concepts::
TreatmentConfirmed
1
geographicAddress:
electronicCommAddr:
standardIndustryClassCode:
1
BusinessObj ects::
StatisticalAnalysisPlan
+
+
+
+
-
birthTime:
sex:
deceasedInd: boolean
deceasedTime:
multipleBirthInd: boolean
multipleBirthOrderNumber: int
organDonorInd: boolean
+
hasHypotheses
relationshipCode: PSMCodedConcept
sequenceNumber: NUMBER
negationIndicator: BOOLEAN
time: TimingSpecification
contactMediumCode: PSMCodedConcept
targetRoleAwarenessCode: PSMCodedConcept
signatureCode: PSMCodedConcept
signature: PSMDescription
slotReservationIndicator: BOOLEAN
substitionConditionCode: PSMCodedConcept
id: PSMID
status: PSMCodedConcept
+
+
+
+
+
+
#
jobCode: PSMCodedConcept
-source
activity
+
confidentialityCode:
Entities and Roles::
Access
Entities and Roles::Person
significanceLevel: double
lowerRejectionRegion: int
upperRejectionRegion: int
testStatistic:
comparisonType: AnalyticComparisonTypes
associatedSummaryVariables:
BasicTypes::ActActRelation
hasAnalysisSets
hasAnalyses
geographicAddress:
maritalStatusCode:
educationLevelCode:
raceCode:
disabilityCode:
livingArrangementCdoe:
electronicCommAddr:
religiousAffiliationCode:
ethnicGroupCode:
kindOfActRelation
kindOfAnalysis
*
Statistical Concepts::
StatisticalAssumption
+
-
*
Protocol Concepts::StudyObj ectiv eRelationship
+
type: PSMCodedConcept
statement: PSMDescription
associatedObjective:
clinicallySignificantDiff: char
AbstractActivity
-_Hypothesis
*
hasAnalyses
+
description: PSMDescription
analysisType: Set{AnalysisTypes}
analysisRole:
rationaleForAnalysisApproach: PSMDescription
associatedStrategy:
associatedHypotheses:
*
manufacturerModelName:
softwareName:
localRemoteControlStateCode:
alertLevelCode:
lastCalibrationTime:
+contains 1
hasModel
OStudy Design and Data Collection::
OBRIDGDeriv ationExpression
BasicTypes::BRIDGInterv al
+
startTime: timestamp
endTime: timestamp
+
+
+
+
description: PSMDescription
outputStatistic: StudyVariable
computations: Set
assumptions: Set
+
+
+
source: Text
version: Text
value: Text
+
+
OProtocolStructure::
ResponsibilityAssignment
code: TEXT
codeSystem:
codeSystemName: TEXT
codeSystemVersion: NUMBER
displayName: TEXT
originalText: TEXT
translation: SET{PSMCodedConcept}
+
+
+
BusinessObj ects::
EnrollmentRecord
randomizationCode:
subjectID:
assignmentDateTime:
alphaSpendingFunction:
timingFunction:
analysis:
trialAdjustmentRule:
effectiveEndDate:
effectiveStartDate:
statusValue:
implements
+
+
+
+
+
+
+
name: TEXT
value:
controlledName: PSMCodedConcept
businessProcessMode: PSMBusinessProcessMode
type: PSMCodedConcept
effectiveTime: BRIDGInterval
usage: PSMCodedConcept
«implementationClass»
BusinessObj ects::
BusinessRule
«implementationClass»
Design Concepts::
ClinicalDecision
description: PSMDescription
algorithm: char
input: AbstractStatisticalParameter
output: AbstractStatisticalParameter
hasSchedules
BusinessObj ects::
SiteSubj ectManagementProj ectPlan
1..*
1
BusinessObj ects::
SiteStudyManagementProj ectPlan
BusinessObj ects::
SponsorStudyManagementProj ectPlan
1 1..*
BusinessObj ects::Inv estigatorRecruitmentPlan
BusinessObj ects::
DataMonitoringCommitteePlan
BusinessObj ects::BiospecimenPlan
BusinessObj ects::
FinalRandomizationAssignment
BusinessObj ects::
Waiv er
BasicTypes::BRIDGContactAddr
«abstraction»
«implementationClass»
Design Concepts::
TemporalRule
AbstractActivity
Statistical Concepts::Computation
-
OProtocolStructure::
Activ ityDeriv edData
BusinessObj ects::Guide
OStudy Design and Data Collection::
OEncounterDefinitionList--???
+
+
+
Implements
BusinessObj ects::
ClinicalTrialMaterialPlans
BusinessObj ects::
RandomizationAssignment
criterion: RULE
eventName: TEXT
Protocol Concepts::Constraint
BasicTypes::BRIDGStatus
run() : bool
+passedTo
+generates 0..*
BasicTypes::BRIDGAnalysisVariable
BasicTypes::BRIDGCodedConcept
-
implements
Statistical Concepts::
SequentialAnalysisStrategy
+
+
+
+
1..* +targetActivity
+sourceActivity 1
Protocol activities and
Safety monitoring (AE)
BusinessObj ects:
:
RegulatoryRecord
type: ENUM{transformation, selection}
rule: TEXT
id: PSMID
name: TEXT
OStudy Design and Data Collection::OBRIDGTransition
BasicTypes::BRIDGID
isExclusive: bool
+
Statistical Concepts::StatisticalModel
+
#
-
Plans::Protocol/Plan
modeValue: ENUM {Plan, Execute}
-
hasAssumptions
hasComputations
1
BasicTypes::BRIDGBusinessProcessMode
BasicTypes::
AbstractRule
description: PSMDescription
Statistical Concepts::Analysis
+
+
+
+
#
#
Entities and Roles::Dev ice
+IsContainedIn
+
«property» relationQualifier() : PSMCodedConcept
«property» sourceAct() : AbstractActivity
«property» destAct() : AbstractActivity
kindOfAnalysis
-_StatisticalAnalysisSet
hasStrategy
-
+
+
+
clinicalJustification: TEXT
Statistical Concepts::Hypothesis
hasChildAnalyses
strain:
genderStatusCode:
description: BRIDGDescription
relationQualifier: BRIDGCodedConcept
mode: PSMBusinessProcessMode
effectiveTime: BRIDGInterval
priorityNumber: NUMBER
negationRule: AbstractRule
detail: char
sourceAct: AbstractActivity
destAct: AbstractActivity
sequence: int
AbstractActivity
businessProcessMode: PSMBusinessProcessMode
code: PSMCodedConcept
derivationExpression: TEXT
status: PSMCodedConcept
+TerminatingActivity 1..*
availabilityTime: TimingSpecification
priorityCode: PSMCodedConcept
confidentialityCode: PSMCodedConcept
repeatNumber: rangeOfIntegers
+EndEvent 1
interruptibleIndicator: BOOLEAN
uncertaintyCode: CodedConcept
+StartEvent 1
reasonCode: PSMCodedConcept
Entities and Roles::
NonPersonLiv ingEntity
+
-
+
-
Statistical Concepts::
SampleSizeCalculation
+FirstActivity 1..*
+
+
+
+
description: char
subgroupVariable: StudyDatum
sequence: int
+
BasicTypes::RIMActivity
+
+
+
+
+
+
+
+
+
+
+
OProtocolStructure::
ElectronicSystem
lotNumberText: string
expirationTime:
stabilityTime:
description: PSMDescription
scopeType: AnalysisScopeTypes
hasCriteria
-source
activity
+target activity
1
Entities and Roles::
ManufacturedMaterial
+
-
Statistical Concepts::HypothesisTest
Entities and Roles::Patient
-
Statistical Concepts::
StatisticalAnalysisSet
hasAnalysisSets
evaluableSubjectDefinition: char
intentToTreatPopulation: char
clinicallyMeaningfulDifference: char
proceduresForMissingData: char
statSoftware: char
methodForMinimizingBias: char
subjectReplacementStrategy: char
randAndStratificationProcedures: char
Statistical Concepts::AnalysisSetCriterion
Entities and Roles::Employee
formCode:
-
-
1..*
Entities and
Roles::Material
«ODM:ItemDef»
Design Concepts::
PlannedObserv ation
restates Objective
*
Entities and Roles::Activ ityRoleRelationship
+
+
+
+
+
* +
+
+
+
+
+
+
OID: long
Name: char
unitOfMeasureID: OID
minValid:
maxValid:
controlledName: ENUM
relationshipCode: PSMCodedConcept
sequenceNumber: NUMBER
pauseCriterion:
checkpointCode:
splitCode:
joinCode:
negationIndicator: BOOLEAN
conjunctionCode:
1
id:
code: PSMCodedConcept
name:
status:
effectiveStartDate:
effectiveEndDate:
geographicAddress:
electronicCommAddr:
certificate/licenseText:
kindOfActivityRelation
subjectID: int
Statistical Concepts::StatisticalConceptArea
* +
+
+
+
+
+
+
+
+
roleInAnalysis: RoleInAnalysisTypes
transactionType:
-
type:
description: PSMDescription
version:
ID: SET PSMID
*
Entities and Roles::Role
«ODM:ItemDef»
Design Concepts::
PlannedInterv ention
kindOf
«abstract»
Design
Concepts::
StudyActivityDef
BusinessObj ects::
SupplementalMaterial
1..*
instantiationType: ENUM {Placeholder, Actual}
id: SET <PSMID>
1
name: string
code: PSMCodedConcept
quantity: int
description: PSMDescription
statusCode: BRIDGStatus
1
existenceTime: BRIDGInterval
riskCode: PSMCodedConcept
handlingCode: PSMCodedConcept
contactInformation: SET <PSMContactAddr>
AbstractActivity
isKindOf
BasicTypes::AnalysisVariableInst
associatedVariable
«ODM ItemData»
Design Concepts::Observ ation
Entities and Roles::
Study
Entities and Roles::Liv ingEntity
Design Concepts::
StudyActiv ityRef
Defined By
as Measured By
Entities and Roles::Entity
Entities and Roles::Organization
activityID: OID
1..*
Protocol Concepts::Outcome
BusinessObj ects::
ProtocolDocument
effectiveEndDate: DATETIME
version:
author: SET
effectiveStartDate: DATETIME
ID: SET PSMID
documentID:
type: ENUMERATED = formal plus non...
description: PSMDescription
title:
status: PSMStatus
confidentialityCode: PSMCodedConcept
businessProcessMode: PSMBusinessProcessMode
+
+
+
+
+
+
+
+
+
+
+
-
«execution mode»
Scheduled Sub Activities
-source
objective
Protocol Concepts::StudyDocument
+
+
+
+
+
+
+
+
+
+
+
+
eventType: UnscheduledEventType
0..*
+source 1
gpsText:
mobileInd: boolean
addr:
directionsText:
positionText:
SubjectEvent
Design Concepts::UnscheduledEv ent
-
hasPurposes
*
Entities and
Roles::
ResearchProgram
+
-
hasUnscheduledEvents
description: PSMDescription
BusinessObj ects::
CommunicationRecord
Entities and Roles::Place
Periods: Set
Tasks: Set
TaskVisits: Set
associatedArms: Set
BusinessObj ects::
Activ itySchedule (the "how ",
"w here", "w hen", "w ho")
BusinessObj ects::
IntegratedDev elopmentPlan
Clinical Trial
Registration
hasArms
Design Concepts::StudySchedule
+
Protocol Concepts::
EligibilityCriterion
listOfDataCollectionInstruments:
Protocol Concepts::
Variance
Protocol Concepts::
ExclusionCriterion
BusinessObj ects:
:ProtocolRev iew
+
+
date:
result:
Protocol Concepts::
Milestone
Eligibility
Determination
Structured
Statistical Analysis
BusinessObj ects::
DataManagementPlan
BusinessObj ects::AssayProcedures
BusinessObj ects::
Adv erseEv entPlan
BusinessObj ects::
ContingencyPlan
BusinessObj ects::
Subj ectRecruitmentPlan
BusinessObj ects::SafetyMonitoringPlan
33
Patient Care
World
Clinical Research
World
An industry initiative that has successfully demonstrated clinical
information interoperability between physician clinical systems and
pharmaceutical clinical trials systems based on open standards.
Data are collected once and subsequently rendered into multiple
formats/systems using CDISC and HL7 standards – streamlines
workflow.
Single Source creates one “source record” for medical data collection
regardless of purpose (patient care or research).
Single Source opens the door for semantic interoperability
34
Patient Safety Institute/CDISC Proposed Single Source for
Safety Monitoring in Clinical Care/Clinical Research
EMR
Provider A
Provider B
PSI Data Cache
PSI Hub
Provider C
Clinical Trial Sponsor
CONNECTIONS LEGEND:
PSI provided connections (HIPAA compliant)
Provider site connections (HIPAA compliant)
Single Source overlay (21 CFR -11 compliant)
Source: L. Bain
35
“The same EHR systems critical for
improving patient care can also help
accelerate clinical research and its impact on
practice and improve pharmaceutical safety
(pharmacovigilance) and biosurveillance for
public health...dual use of EHR systems that
could reduce total system costs.”
Slide Courtesy Meredith Nahm
36
data
conception
Healthcare
Delivery
(e)Source
Documents
EHR
eSource
(e)CRFs
Clinical
Research
auto
reconciliation
and archive
Can we not make it easier
for the investigative sites and
ourselves to do clinical trials?
37
eSource Data Interchange (eSDI)
• Purpose of eSDI Initiative
– to facilitate the use of electronic technology in the context of
existing regulations for the collection of source data in clinical
trials for regulatory submission by leveraging the power of the
CDISC standards, in particular the Operational Data Model
(ODM).
– Note: eSource pertains to eDiaries, ePRO, eDCI, Electronic
Health Records…
• Document Posted for Open Public Review and
Comment by 17 October
38
Standard CRF Generation, Viewing Metadata and Data
Review and Archive
ODM
XML
XSLT
Transformation
ACRO: SDTM can provide standard
content/format for standard CRFs
ODM
XML
XSLT
Transformation
Source: Dave Iberson-Hurst, Assero
39
Data Flow Using CDISC Standard Linking Clinical
Research and Healthcare
= ODM (transport)
Electronic
Health Record
= SDTM and Analysis Data (content)
= Protocol information (content)
Patient Info
HL7 or
ODM XML
HL7 or
ODM XML
= Source data
(other than SDTM/CRF data)
Clinical Trial
Data
Protocol
Representation
Trial Design
(SDTM)
Analysis Plan
Clinical Trial
Protocol
Patient Info
ODM
XML
Clinical
(CRF or eCRF)
Trial Data
(defined by
SDTM)
(e)Source
Document
Integrated
Reports
Administrative,
Tracking, Lab
Acquisition Info
ODM
XML
CRF, Analysis
Data
Operational &
Analysis
Databases
ODM XML
Define.xml
SDTM Data,
Analysis
Data,
Metadata
Regulatory
Submissions
40
CDISC in the “World of Standards” 2003
International Conference on
Harmonization (ICH)
EFPIA
JPMA
EMEA
MHLW
KIKO
U.S. Dept. of Health and Human Services
(HHS)
PhRMA
U.S. FDA
Protocol Std
CDISC
ADaM SDS ODM LAB
MedDRA
= Dictionary,
Codelist
NIH/NCI
NLM
DICOM
TC:
RCRIM
Health Level 7 (HL7)
Reference
Information Model
RIM
= Standard
ISO
LOINC
SNOMED
Clinical
Document
Architecture
eCTD
= Organization
CDC
= Model
= Document Standard,
or Architecture
41
CDISC in the “World of Standards” 2005
International Conference on
Harmonization (ICH)
EFPIA
JPMA
EMEA
MHLW
U.S. Dept. of Health and Human Services
(HHS)
PhRMA
U.S. FDA
TC:
RCRIM
CDISC
ADaM SDS ODM
LAB
MedDRA
Protocol
Representation
NIH/NCI
CDC
NLM
Health Level 7 (HL7)
Reference
Information Model
RIM
SNOMED
LOINC
CDA
eCTD
= Organization
= Dictionary,
Codelist
= Standard
= Model
= Document Standard,
or Architecture
42
CDISC in the “World of Standards” 2005
International Conference on
Harmonization (ICH)
EFPIA
JPMA
EMEA
MHLW
PhRMA
U.S. Dept. of Health and Human Services
(HHS)
U.S. FDA
NIH/NCI
CDC
NLM
RCRIM Technical Committee
CDISC
ADaM SDS ODM
Health Level 7 (HL7)
LAB
MedDRA
Protocol
Representation
Reference
Information Model
RIM
SNOMED
LOINC
CDA
eCTD
= Organization
= Dictionary,
Codelist
= Standard
= Model
= Document Standard,
or Architecture
43
CDISC in the “World of Standards” 2005
International Conference on
Harmonization (ICH)
EFPIA
JPMA
EMEA
MHLW
PhRMA
U.S. Dept. of Health and Human Services
(HHS)
U.S. FDA
NIH/NCI
CDC
NLM
RCRIM Technical Committee
CDISC
ADaM SDS ODM
Health Level 7 (HL7)
LAB
MedDRA
Protocol
Representation
eCTD
= Organization
Reference
Information Model
RIM
SNOMED
LOINC
CDA
BRIDG Model
= Dictionary,
Codelist
= Standard
= Model
= Document Standard,
or Architecture
44
CDISC in the “World of Standards” 2005
World Health Organization (WHO)
International Conference on
Harmonization (ICH)
EFPIA
JPMA
EMEA
MHLW
PhRMA
U.S. Dept. of Health and Human Services
(HHS)
U.S. FDA
NIH/NCI
CDC
NLM
RCRIM Technical Committee
CDISC
ADaM SDS ODM
Health Level 7 (HL7)
LAB
MedDRA
Protocol
Representation
eCTD
= Organization
Reference
Information Model
RIM
SNOMED
LOINC
CDA
BRIDG Model
= Dictionary,
Codelist
= Standard
= Model
= Document Standard,
or Architecture
45
“ Politics are almost as exciting as war, and quite
as dangerous.
In war you can only be killed once, but in politics
many times.”
> Winston
Churchill
46
CDISC Board/IAB/TCC Strategic Planning:
Today’s Clinical Research Environment
• More intense focus on patient safety and
pharmacovigilance
• Need for transparency of clinical information
through publicly accessible registries and
databases
• Direct data capture tools are now available
• Importance of interoperability
• Increasing focus on electronic healthcare
records
47
CDISC Board/IAB/TCC Strategic Planning
• Board Committee, with input from Industry
Advisory Board (3 Board Members, 2 IAB Cochairs, 2 Operations), is working on CDISC
Strategic Plan 2006 – 08
• CDISC Technical Roadmap and Input from IAB,
TCC (environment and needs) will be
incorporated
• To be completed by December 2005, with
operational plan and budget
• David Hardison, PhD will be Board Chair 2006
• Ed Helton, PhD will be Board Chair-elect 2006
48
Knowing is not enough;
we must apply.
Willing is not enough;
we must do.
- Goethe-
To the gracious supporters who
‘apply’ and ‘do’….
THANK YOU!
Rebecca Kush
rkush@cdisc.org
49
Information and Contacts
• For standards and information, see www.cdisc.org
• eNewsletters available via e-mail; contact Shirley Williams
swilliams@cdisc.org or sign up on the CDISC website.
• Technical questions: Julie Evans jevans@cdisc.org or Public
Discussion Forum
• Education and Membership: Frank Newby fnewby@cdisc.org
• Rebecca Kush: rkush@cdisc.org
50