The CIP-creator GPT input yaml file

What the YAML is for

• Validation: The GPT checks required data, format, and consistency and returns a Gap Report when something is missing or conflicting.
• Generation: When valid, it creates a jurisdiction-aligned CIP skeleton (swissethics for CH, ISO 14155/MDR for EU) and then drafts sections using your Plans.

File rules & formatting

• Filename: any .yaml or .yml.
• Encoding: UTF-8. Dates as YYYY-MM-DD.
• Empty values ("", null, [], {}) are treated as missing unless you set not_applicable: true on that subsection.
• If multiple YAML documents are in one file, the GPT reads the first document with meta.schema_version.
• Indent with 2 spaces. No tabs.

Minimal valid example (for orientation)

meta:
  schema_version: "1.0"

jurisdiction:
  track: CH    # or EU / CH+EU / Other
  ch:
    clinO_MD_category: C2
    swissmedic_involved: true
    basec_lead_ec: "KEK BE"

identification:
  full_title: "Feasibility of MRSI X at 7T"
  investigation_id: "MRSI7T-001"
  cip_version: "1.0"
  cip_date: "2025-10-02"

sponsor_setup:
  sponsor_model: "Sponsor-Investigator"
  sponsor:
    name: "Inselspital Bern"
  coordinating_investigator:
    name: "Dr. A. Example"

medical_device:
  name: "MRSI-X Software + Dual-Tuned Head Coil"
  manufacturer:
    name: "Lab ABC"
  mdr_class: "IIa"
  mdr_rule: "11"

categorisation:
  rationale: "Investigational use beyond CE intended purpose (software affects diagnosis)."

synopsis:
  primary_objective: "Assess feasibility and data quality of MRSI-X."
  primary_endpoint: "Acquisition success rate per subject."
  sample_size_total: 15
  sample_size_rationale: "Feasibility sample; precision target ±10%."

population:
  inclusion_criteria:
    - "Adults 18–80"
  exclusion_criteria:
    - "MRI contraindications"

procedures:
  visit_schedule:
    - visit_id: "V1"
      name: "Baseline & Imaging"
      window: "Day 0"
      procedures: ["Consent","Safety check","MR scan","Questionnaire"]
    - visit_id: "V2"
      name: "Follow-up"
      window: "Day 14 ±3"
      procedures: ["AE check"]

safety:
  path: "C"
  reporting:
    to_sponsor_hours:
      sae: 24

data_quality_privacy:
  archiving_period_years: 10

ethics_and_regulatory:
  patient_information_icf_plan: "Single IC at V1; lay summary provided."

insurance:
  provider: "Swiss Research Insurance AG"

publication_and_dissemination:
  plan: "Authorship per ICMJE; preprint & code repository after acceptance."

signatures:
  sponsor:
    name: "Inselspital Bern"

revision_history:
  - version: "1.0"
    date: "2025-10-02"

registration:
  primary_registry: "BASEC-Human Research"
  registry_id: "TBD-HumRes"

Full scaffold (copy & adapt)

Use this when starting from scratch. Delete rows you do not use and fill all placeholders. Add not_applicable: true only when a whole subsection truly does not apply.

meta:
  schema_version: "1.0"

jurisdiction:
  track: CH          # CH | EU | CH+EU | Other
  ch:
    clinO_MD_category: C1        # A1/A2/C1/C2/C3
    swissmedic_involved: false   # must be true if safety.path == "C"
    basec_lead_ec: ""
  eu:
    lead_member_state: ""
    sponsor_srn: ""
    manufacturer_srn: ""
    eudamed_civ_id: ""           # optional but recommended
  other:
    authority_name: ""           # only if track == Other

identification:
  full_title: ""
  short_title: ""
  investigation_id: ""
  cip_version: ""
  cip_date: "YYYY-MM-DD"

sponsor_setup:
  sponsor_model: ""              # e.g., Sponsor, Sponsor-Investigator
  sponsor:
    name: ""
    address: ""
  coordinating_investigator:
    name: ""
    affiliation: ""
  statistician:
    name: ""                     # required unless not_applicable:true
    not_applicable: false

medical_device:
  name: ""
  description: ""
  manufacturer:
    name: ""
  ce_marked: false
  intended_purpose: ""
  investigational_use_description: ""
  mdr_class: ""                  # e.g., IIa
  mdr_rule: ""                   # e.g., 11
  radiation_exposure:
    applicable: false
    details: ""                  # required if applicable:true

categorisation:
  rationale: ""                  # explain investigational/off-label basis

synopsis:
  primary_objective: ""
  secondary_objectives: []
  primary_endpoint: ""
  secondary_endpoints: []
  sample_size_total: 0
  sample_size_rationale: ""

population:
  inclusion_criteria: []
  exclusion_criteria: []

procedures:
  visit_schedule: []             # one or more visits; see example below

safety:
  path: "A"                      # "A" or "C"
  reporting:
    to_sponsor_hours:
      sae: 24                    # integer hours to notify sponsor
  stopping_rules: ""
  device_deficiencies: "Recorded and reported per plan."

data_quality_privacy:
  monitoring_plan: ""
  audits: "As needed."
  inspector_access: "Permitted."
  archiving_period_years: 10
  data_privacy_plan: "Pseudonymization, secure transfer, controlled access."

ethics_and_regulatory:
  patient_information_icf_plan: ""
  lay_summary_plan: "To be published post-study."

insurance:
  provider: ""

publication_and_dissemination:
  plan: ""

registration:
  primary_registry: ""
  registry_id: ""

signatures:
  sponsor:
    name: ""

revision_history:
  - version: ""
    date: "YYYY-MM-DD"

Field-by-field guide — Core (all jurisdictions)

Field-by-field guide — CH specific

Field-by-field guide — EU specific

Conditional & cross-field logic the validator enforces

• If safety.path = "C" and jurisdiction.track includes CH → jurisdiction.ch.swissmedic_involved must be true.
• If medical_device.ce_marked = trueand use is beyond the intended purpose → categorisation.rationale must explicitly state investigational/off-label basis.
• If statistician.not_applicable is not true → sponsor_setup.statistician.name is required.
• If medical_device.radiation_exposure.applicable = true → …details is required.
• Visit schedule: must contain ≥ 1 visit object; each should include a human-readable window and list of procedures.

Visit schedule — compact example

procedures:
  visit_schedule:
    - visit_id: "SCR"
      name: "Screening"
      window: "Day −14 to −1"
      procedures: ["Consent","Eligibility","Safety checklist"]
    - visit_id: "BL/IMG"
      name: "Baseline + Imaging"
      window: "Day 0"
      procedures: ["Vitals","MR scan (no contrast)","Questionnaire"]
    - visit_id: "FU"
      name: "Follow-up"
      window: "Day 14 ±3"
      procedures: ["AE query","Device deficiency review"]

Typical validation errors & how to fix

• Missing schema version: Add meta.schema_version: "1.0".
• Unknown jurisdiction: Set jurisdiction.track to one of CH, EU, CH+EU, Other.
• Empty required fields: Replace ""/[]/null with real values. Do not mark single fields as not_applicable unless the whole subsection is truly not applicable.
• Sample size zero: Set synopsis.sample_size_total to ≥ 1 and justify in …rationale.
• Path C without Swissmedic: Set jurisdiction.ch.swissmedic_involved: true.
• Radiation applicable but details missing: Fill medical_device.radiation_exposure.details.
• No visits defined: Add at least one item under procedures.visit_schedule.

Before you upload — quick checklist

• Dates use YYYY-MM-DD; indentation is consistent.
• meta.schema_version is exactly "1.0".
• Jurisdiction track selected; CH/EU extras completed.
• Device class & rule present; categorisation rationale clear.
• Objective, endpoint, sample size & rationale filled.
• Inclusion & exclusion lists populated.
• Visit schedule present (≥ 1 visit).
• Safety path set; SAE reporting hours set.
• Archiving period, ICF plan, insurance provider, publication plan present.
• Sponsor signature name present; first revision row completed.

FAQ