create_ctxml {spiritR} | R Documentation |
Creates xml document for upload to clinicaltrials.gov
Description
This function will create an xml document conforming to clinicaltrials.gov requirements for automatic upload to the registry
Usage
create_ctxml(org_name, org_study_id, brief_title, study_acronym,
official_title, agency, resp_party_type, investigator_username,
investigator_title, brief_summary, start_date, study_compl,
primary_compl, int_subtype, phase, assignment, allocation, no_masking,
masked_subject, masked_caregiver, masked_investigator, masked_assessor,
number_arms, sample_size, eligibility_criteria, healthy_volunteers,
genders_included, gender_based, min_age, max_age, official_first_name,
official_last_name, official_degrees, official_role,
official_affiliation, contact_first_name, contact_last_name,
contact_degrees, contact_phone, contact_email, ipd_sharing,
ipd_description, ipd_protocol, ipd_sap, ipd_icf, ipd_csr, ipd_code,
ipd_time, ipd_criteria, ipd_url)
Arguments
org_name |
The code for the organisation name associated with your PRS clinicaltrials.gov log-in details. |
org_study_id |
Must be a unique study number from the organization. Sometimes it is the number associated with the funding received or submission for institutional approval. |
brief_title |
Brief title for the study with a limit of 300 characters |
study_acronym |
limit to 14 characters or enter n/a |
official_title |
Study title limited to 600 characters |
agency |
Name of the lead sponsor. This would be the name of the principal investigator if it is a Sponsor-Investigator trial. |
resp_party_type |
Either: Sponsor; Principal Investigator (responsible party designated by sponsor) or Sponsor-Investigator (individual who initiates and conducts study). |
investigator_username |
The username associated with your clinicaltrials.gov log-in |
investigator_title |
Offical title e.g. Assistant Professor |
brief_summary |
A short description of the clinical study, including a brief statement of the clinical study's hypothesis, written in language intended for the lay public. Limit is 5000 characters. |
start_date |
Anticipated start date written in yyyy-mm format |
study_compl |
The anticipated date (written in yyyy-mm) that the final participant was examined or received an intervention for purposes of final collection of data |
primary_compl |
Anticipated date written in yyyy-mm-dd format. The date that the final participant was examined or received an intervention for the purposes of final collection of data for the primary outcome. |
int_subtype |
Either: Treatment; Prevention; Diagnostic; Supportive Care; Screening; Health Services Research; Basic Science; Device Feasibility; or Other. |
phase |
Either: N/A (for trials that do not involve drug or biologic products); Early Phase 1; Phase1/Phase 2; Phase 2; Phase2/Phase 3; Phase 3; or Phase 4. |
assignment |
Either: Single group; Parallel; Crossover; Factorial; or Sequential. |
allocation |
Either: Randomized; or Non-randomized. |
no_masking |
True/False |
masked_subject |
True/False |
masked_caregiver |
True/False |
masked_investigator |
True/False |
masked_assessor |
True/False |
number_arms |
Number of arms. "Arm" means a pre-specified group or subgroup of participant(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol. |
sample_size |
Planned sample size |
eligibility_criteria |
Textbox contaiing both inclusion and exclusion criteria |
healthy_volunteers |
Trial is recruiting healthy volunteers for participation. Answer is either: Yes; or No. |
genders_included |
Either: Female; Male; or Both. |
gender_based |
If applicable, indicate if eligibility is based on self-representation of gender identitiy. Answer is either: Yes; or No. |
min_age |
Numeric with years - e.g. 16 years or 'N/A (No Limit)' |
max_age |
Numeric with years - e.g. 80 years or 'N/A (No Limit)' |
official_first_name |
Overall official first name |
official_last_name |
Overall official last name |
official_degrees |
Overall official degrees/qualifications |
official_role |
Either: Study Chair; Study Director or Study Principal Investigator. |
official_affiliation |
Full name of the official's organization. If none, specify Unaffiliated. |
contact_first_name |
Central contact first name |
contact_last_name |
Central contact last name |
contact_degrees |
Central contact's degrees/qualifications |
contact_phone |
Central contact phone number |
contact_email |
Central contact email |
ipd_sharing |
Indicate whether there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers (typically after the end of the study). Either: Yes; No; Undecided. |
ipd_description |
If yes, describe the IPD sharing plan, including what IPD are to be shared with other researchers. |
ipd_protocol |
Study protocol to be shared: True/False |
ipd_sap |
Statistical analysis plan to be shared: True/False |
ipd_icf |
Information consent form to be shared: True/False |
ipd_csr |
Clinical study report to be shared: True/False |
ipd_code |
Analytic code to be shared: True/False |
ipd_time |
A description of when the IPD and any additional supporting information will become available and for how long, including the start and end dates or period of availability. Limit 1000 characters. |
ipd_criteria |
Describe by what access criteria IPD and any additional supporting information will be shared, including with whom, for what types of analyses, and by what mechanism. Limit 1000 characters. |
ipd_url |
The web address, if any, used to find additional information about the plan to share IPD. |
Value
A xml document
Examples
args_ctxml <- list(
org_name = "UHNToronto",
org_study_id = "Foo trial 20190806",
brief_title = "Foo trial to test auto upload 20190806",
study_acronym = "N/A",
official_title = "Foo trial to test auto upload: A randomized trial new 20190806",
agency = "Aaron Conway",
resp_party_type = "Sponsor-Investigator",
investigator_username = "aconway",
investigator_title ="Assistant Professor",
brief_summary = "Lay summary here",
start_date = "2019-10",
primary_compl = "2020-12",
study_compl = "2020-12",
int_subtype = "Health Services Research",
phase = "N/A",
assignment = "Parallel",
allocation = "Randomized",
no_masking = "False",
masked_subject = "True",
masked_caregiver = "True",
masked_investigator = "True",
masked_assessor = "True",
number_arms = 2,
sample_size = "40",
eligibility_criteria = "Inclusion Criteria
- Adults
Exclusion Criteria
- Children",
healthy_volunteers = "No",
genders_included = "Both",
gender_based = "No",
min_age = "1 years",
max_age = "N/A",
#Central contact
contact_first_name = "Aaron",
contact_last_name = "Conway",
contact_degrees = "PhD",
contact_phone = "649-728-8499",
contact_email = "aaron.conway@utoronto.ca",
#Overall official
official_first_name = "Aaron",
official_last_name ="Conway",
official_degrees = "PhD",
official_affiliation = "UHN",
official_role = "Study Principal Investigator",
#Sharing statements
ipd_sharing = "Yes",
ipd_description = "details",
ipd_protocol = "True",
ipd_sap = "True",
ipd_icf = "True",
ipd_csr = "True",
ipd_code = "True",
ipd_time = "details",
ipd_criteria = "details",
ipd_url = "http://www.aaronconway.info"
)
ctxml <- do.call(create_ctxml, args_ctxml)