create_ctxml: Creates xml document for upload to clinicaltrials.gov
In spiritR: Template for Clinical Trial Protocol

Description Usage Arguments Value Examples

View source: R/create_ctxml.R

This function will create an xml document conforming to clinicaltrials.gov requirements for automatic upload to the registry

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)

`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.

A xml document

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)