create_ctxml {spiritR}

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 = "[e-mail]",
#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)