Structure LinkId Text Cardinality Type Flags Description & Constraints SIRBDeterminationQuestionnaire Questionnaire http://hl7.org/fhir/us/sirb/Questionnaire/sirb-determination-letter-questionnaire-populate#1.0.0 dl1 Research Study 0..1 group dl1.1 Study Title 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value dl1.1_help Short Title of the Research Study 0..1 display dl1.2 IRB Protocol Number 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value dl1.2_help IRB number assigned by the site institution 0..1 display dl2 Reliance Determination 0..1 group dl2.1 sIRB (Reviewing Institution) 0..1 group dl2.1.1 Institution 0..1 group dl2.1.1.1 sIRB (Reviewing Institution) Name 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value dl2.1.1.2 Federal Wide Assurance (FWA) 0..1 integer Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in6.9').answer.value dl2.1.1.2_help DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA. 0..1 display dl2.1.1_help Institution providing overall review of research study activities for most sites enrolling participants in a researach study. Its role is to protect the rights and welfare of human research participants. It has the authority to approve and require modifications of all research activities that fall within its jurisdiction for all relying sites. 0..1 display dl2.1_help IRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network. 0..1 display dl2.2 Determination Decision 1..1 choice Options: 2 options dl5 Lead Principal Investigator Responsible for Overall Study 0..1 group dl5.1 First Name 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value dl5.1_help First or Given name of the lead principal investigator 0..1 display dl5.2 Last Name 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value dl5.2_help Surname or family name 0..1 display dl5.4 Suffix 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value dl5.4_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display dl5.5 Degree(s) 0..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value dl5.5_help Professional and Academic degrees of the lead principal investigator 0..1 display dl5.3 Email 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value dl5_help Prinicpal investigator leading the study, ultimately responsible for the overall conduct of the study 0..1 display dl11 Lead Principal Investigator Institution 0..1 group dl11.1 Lead Principal Investigator Institution Name 1..1 string Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value dl7 Relying IRB 0..1 group dl7.5 Relying institution and Relying Site Principal Investigator for this Determination Letter 0..1 group ExternalDataFor_dl7.5.1 External Data For linkId dl7.5.1 0..* open-choice Expressions: Initial Value: %lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value dl7.5.1 Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below. 0..1 choice dl7.5.1_help This question and its answer will not print on the Determination Letter but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details. 0..1 display dl7.1 Relying Institution 0..1 group dl7.1.1 Name 1..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value dl7.1.2 Federal Wide Assurance (FWA) 0..1 integer Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.5').answer.value dl7.1.2_help DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA. 0..1 display dl7.1_help Name of Institution where its IRB has agreed to IRB oversite by the reviewing IRB (sIRB) 0..1 display dl7.2 Relying Site Principal Investigator 0..1 group dl7.2.1 First Name 1..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value dl7.2.1_help First or Given name of the site investigator 0..1 display dl7.2.2 Last Name 1..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value dl7.2.2_help Surname or family name 0..1 display dl7.2.4 Suffix 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value dl7.2.4_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display dl7.2.5 Professional Degree(s) 0..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value dl7.2.5_help Professional and Academic degrees of the site investigator 0..1 display dl7.2.3 Email 1..1 string Expressions: Calculated Value: %lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value dl7.2_help Site principal investigator responsible for the conduct of the study at the relying site research location for which this Determination Letter is being created 0..1 display dl7_help IRB at relying institution that has agreed to IRB oversite by the reviewing IRB (sIRB) 0..1 display dl9 Point of Contact for Study Participants 0..1 group dl9_help Primary person with whom a study participant will interact: may be PI or study coordinator or other designated personnel. 0..1 display dl9.1 First Name 1..1 string dl9.1_help First or given name of the point of contact 0..1 display dl9.2 Last Name 1..1 string dl9.2_help Surname or family name 0..1 display dl9.4 Suffix 0..1 string dl9.4_help Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc. 0..1 display dl9.5 Professional Degree(s) 0..1 string dl9.5_help Professional and Academic degrees of the point of contact 0..1 display dl9.3 Email 1..1 string ADMIN00 Administrative Use Only 0..1 group ADMIN01 Link ID prefix 0..1 string Initial Value: string = dl ADMIN02 Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value ADMIN03 ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any 0..1 string Initial Value: string = temporarily unavailable Expressions: Initial Value: %lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value ADMIN04 Questionnaire Response ID of the local considerations Questionnaire Response, if any 0..1 string Documentation for this format Option Sets Answer options for dl2.2 http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#AR ("Accepts Review") http://hl7.org/fhir/us/sirb/CodeSystem/temporarycodes#DR ("Denies Review")
The content of the Questionnaire Response transferred to this Questionnaire during form launch
The Initiate a Study Questionnaire Response content that will be used to pre-populate this Questionnaire
variable to store the incoming data from the launchContext extension for populate and other expressions
site that the determination letter pertains to
%resource.descendants().where(linkId = 'dl7.5.1').answer.valueCoding.display
HL7 International - Biomedical Research and Regulation
%lookupInitiateStudy.descendants().where(linkId = 'in1.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in1.3').answer.value
IRB number assigned by the site institution
%lookupInitiateStudy.descendants().where(linkId = 'in6.1').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in6.9').answer.value
DHHS assigned number indicating Assurance of Compliance with the Office of Human Research Protections. Enter just the numeric value of the FWA.
Institution providing overall review of research study activities for most sites enrolling participants in a researach study. Its role is to protect the rights and welfare of human research participants. It has the authority to approve and require modifications of all research activities that fall within its jurisdiction for all relying sites.
IRB responsible for the overall approval of the study, and whose approval will then stand for the relying institutions in the network.
Lead Principal Investigator Responsible for Overall Study
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.1').answer.value
First or Given name of the lead principal investigator
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.2').answer.value
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.3').answer.value
Suffix such as Junior (Jr.), Senior (Sr.), I, II, III, IV, etc.
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.4').answer.value
Professional and Academic degrees of the lead principal investigator
%lookupInitiateStudy.descendants().where(linkId = 'in7.3.6').answer.value
Prinicpal investigator leading the study, ultimately responsible for the overall conduct of the study
%lookupInitiateStudy.descendants().where(linkId = 'in7.1.1').answer.value
Lead Principal Investigator Institution Name
Relying institution and Relying Site Principal Investigator for this Determination Letter
%lookupInitiateStudy.repeat(item).where(linkId = 'in8.9').answer.value
See FHIR Specification Feedback Jira ticket FHIR-36338. Information obtained from other types of external sources (e.g. launch context, fhir-x-query, etc.) SHOULD only be used for initialExpression and calculatedExpression logic. Other behavior such as enableWhen or answerExpression should always be driven off of answers within the Questionnaire (even if they are hidden answers that are populated from an initialExpression).
%resource.repeat(item).where(linkId = 'ExternalDataFor_dl7.5.1').answer.value
Select the relying site in order to pre-populate the relying institution and relying site principal investigator details below.
This question and its answer will not print on the Determination Letter but are necessary for the form logic. If you do not want pre-population to occur, leave this question blank and manually fill in the relying institution and relying site principal investigator details.
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.1').answer.value
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.1.5').answer.value
Name of Institution where its IRB has agreed to IRB oversite by the reviewing IRB (sIRB)
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.1').answer.value
First or Given name of the site investigator
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.2').answer.value
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.3').answer.value
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.4').answer.value
Professional and Academic degrees of the site investigator
%lookupInitiateStudy.descendants().where(item.where(linkId = 'in8.9' and answer.value = %relyingSiteForForm)).item.descendants().where(linkId = 'in8.3.6').answer.value
Site principal investigator responsible for the conduct of the study at the relying site research location for which this Determination Letter is being created
IRB at relying institution that has agreed to IRB oversite by the reviewing IRB (sIRB)
Primary person with whom a study participant will interact: may be PI or study coordinator or other designated personnel.
First or given name of the point of contact
Professional and Academic degrees of the point of contact
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN02').answer.value
Questionnaire Response ID for the parent Questionnaire Response (such as the Initiate a Study Questionnaire Response), if any
%lookupInitiateStudy.descendants().where(linkId = 'ADMIN03').answer.value
ID of the Research Study FHIR Resource associated with the study Questionnaire Responses, if any
Questionnaire Response ID of the local considerations Questionnaire Response, if any