Clinical Trial Pre-Screening
An encrypted clinical trial pre-screening eligibility form compliant with Swiss HFG (Humanforschungsgesetz), ICH GCP E6 and GDPR Art. 9. Collects demographics, diagnosis, medications, exclusion criteria and contact details.
About this template
This template gives research sites, CROs and academic medical centres a structured pre-screening eligibility form for clinical trials. It captures the key demographic and clinical data needed to determine whether a potential participant meets a study's inclusion criteria before a formal screening visit is scheduled. All submissions are encrypted end-to-end in compliance with Swiss HFG and GDPR Article 9.
What it collects
- Age and biological sex for eligibility matching
- Primary diagnosis or medical condition relevant to the trial
- Current medications and dosages
- Prior clinical trial participation
- Exclusion criteria self-check (pregnancy, specific conditions)
- Relevant co-morbidities
- Contact details for follow-up scheduling
- Signature confirming voluntary participation and data consent
Swiss HFG and ICH GCP compliance
Health data collected during pre-screening is special-category data under GDPR Article 9 and the Swiss Humanforschungsgesetz (HFG). This form captures explicit consent, collects minimum necessary data and uses end-to-end encryption so only the authorised research team can access responses.
How to use it
Use this template
Click 'Use template' to create a copy in your dashboard.
Add study-specific criteria
Insert your protocol's inclusion and exclusion criteria as additional questions or update the existing choice lists.
Distribute to candidates
Share the encrypted link via email or patient portal once a candidate expresses interest.
Review eligibility
Download encrypted responses, assess eligibility against the protocol and schedule formal screening for qualified candidates.
Why clinical trials need a structured pre-screening form
Screen failure is one of the largest controllable costs in clinical research. A formal screening visit typically costs several hundred Swiss francs in staff time, laboratory tests and investigator review. When a candidate is screened in person only to be excluded for a basic criterion — age, an active contraindicated medication or a prior diagnosis — that cost is entirely avoidable. A structured digital pre-screening form administered before the visit eliminates the most common screen failures at near-zero marginal cost.
Pre-screening also protects prospective participants. Identifying an exclusion criterion before a patient travels to a research site, undergoes preliminary tests and invests emotional energy in participation is more ethical than discovering incompatibility during a formal visit. The Swiss HFG requires that research involving human participants be proportionate and that participant burden be minimised — digital pre-screening directly fulfils both obligations.
What a clinical trial pre-screening form should include
An effective pre-screening instrument covers the following dimensions:
- Age and sex — fundamental eligibility axes for most protocols
- Target condition — the primary diagnosis or biomarker status relevant to the trial
- Comorbidities — conditions that commonly appear as exclusion criteria
- Concomitant medications — many trials exclude specific drug classes due to interaction risk
- Prior trial participation — wash-out periods and cross-contamination risk
- Pregnancy and contraception status — near-universal exclusion criterion in phase I/II
- Contact details — for follow-up scheduling only, handled under data minimisation principles
- Consent to pre-screening data processing — explicitly required under HFG Art. 16
Regulatory framework: HFG, ICH GCP E6 and GDPR
Switzerland's Humanforschungsgesetz (HFG) governs all research involving human participants, including pre-screening activities. Article 16 requires participants to consent to the collection and use of their personal data before any research-related activity. ICH GCP E6 (R2) requires that subject identification and eligibility data be captured and retained with source document integrity. GDPR Article 9 classifies health data as special-category data requiring explicit consent and appropriate technical measures. This form addresses all three frameworks: it captures explicit consent, is encrypted end-to-end, and creates an auditable record of pre-screening data.
Frequently asked questions
Does pre-screening constitute formal enrolment under HFG?
No. Pre-screening is a preliminary eligibility check and does not constitute enrolment. Formal informed consent under HFG Art. 16 must still be obtained before the participant undergoes any study procedure. This form captures consent to pre-screening data processing only.
Can we use responses as source data in the trial master file?
Encrypted form responses can serve as source documents if your data management plan designates them as such and your system is validated appropriately. Consult your data manager and sponsor before designating digital pre-screening records as primary source data.
How long should pre-screening data be retained?
ICH E6 requires retention of trial-related records for at least 15 years after study completion or termination. Swiss HFG Article 47 specifies retention periods aligned with Swissmedic requirements. Configure your retention policy accordingly before activating the form.