📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The Informed Consent Form template — the document a subject reads and signs before joining the trial.
Why it exists. Ethical research requires voluntary, informed consent. The ICF explains the study, risks, benefits, and rights in plain language; it is reviewed by the ethics committee and is a foundational GCP document.
How it is produced here. It is an operational trial document — a plan, charter, or template of the kind kept in the Trial Master File. It describes how the trial is run, rather than reporting the trial's results.
Format & governing standard. ICH E6(R3) §4.8; Declaration of Helsinki (2013); 21 CFR 50; EU CTR 536/2014; local IRB/IEC
| Field | Value |
|---|---|
| Document ID | TMF-ICF |
| Version | 2.0 |
| Status | Final (master template) |
| Study No. | GLPI103-301 |
| Sponsor | Virtual Biopharma Inc. |
| Standard | ICH E6(R3) §4.8; Declaration of Helsinki (2013); 21 CFR 50; EU CTR 536/2014; local IRB/IEC |
| Confidentiality | Confidential — TMF |
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Master, region-neutral participant-facing consent document. Site- and region-specific versions (US/EU/KR), including the separate genetic/biomarker sub-study consent, are localized into plain local language and IRB/IEC-approved before use.
[MOCK]— illustrative template.
| Version | Date | Author | Summary of Change |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical | Initial ICF template (key-elements summary) |
| 2.0 | 2026-07-05 | Clinical / Medical Writing | Full participant-facing form — expanded to complete ICH E6(R3) §4.8 element set with plain-language sections and signature blocks |
You are being invited to take part in a research study. Before you decide, it is important that you understand why the research is being done and what it will involve. Please take time to read this information carefully and discuss it with others if you wish. Ask us if anything is unclear or if you would like more information. Take time to decide whether or not you wish to take part. Your participation is entirely voluntary.
This study is testing an investigational medicine called GLPI-103 for adults with type 2 diabetes whose blood sugar is not well controlled on metformin. GLPI-103 works on two body signals (the GLP-1 and apelin/APJ pathways) that affect blood sugar and body weight. The study compares GLPI-103 with an approved medicine, oral semaglutide, to see whether GLPI-103 lowers a blood-sugar marker (HbA1c) more over one year.
You have been invited because you are an adult with type 2 diabetes taking metformin and your blood sugar is above target. About 900 people will take part across multiple study centres.
No. Taking part is your choice. If you decide to take part, you will be asked to sign this form. You are still free to withdraw at any time, without giving a reason, and without your normal medical care or legal rights being affected.
The most common side-effects of this type of medicine affect the stomach and gut: nausea (feeling sick), vomiting, diarrhoea, and reduced appetite. These are usually mild to moderate and often improve with the slow dose increase. Other possible risks include low blood sugar (hypoglycaemia) — more likely if you take other diabetes medicines — and injection-site reactions. There are warnings for this class of medicine about inflammation of the pancreas (pancreatitis) and a type of thyroid tumour seen in animal studies; you should not take part if you or a family member has had medullary thyroid cancer or the syndrome MEN 2. Blood draws may cause discomfort or bruising. There may be risks that are not yet known. If you are pregnant, may become pregnant, or are breastfeeding, you should not take part; effective contraception is required.
Your blood-sugar control and weight may improve while you are in the study, but this cannot be promised. The information from this study may help people with diabetes in the future.
You do not have to join this study to treat your diabetes. Other approved diabetes medicines are available; your doctor can discuss these with you.
Yes. Your information will be handled confidentially. You will be identified by a code, not your name. Your coded information may be looked at by the sponsor and its representatives, study monitors, auditors, ethics committees, and health authorities, who may check the study is being run properly. Results may be published or shared but will not identify you. Your data will be processed in line with applicable data-protection law (e.g., GDPR in the EU; local law in the US and Korea).
If you are harmed as a direct result of taking part, arrangements for care and, where applicable, compensation apply per the sponsor's clinical-trial insurance and local law. If you have concerns, you can contact the study doctor or the ethics committee using the details below.
Your participation is voluntary and you may stop at any time without penalty or loss of benefits to which you are otherwise entitled. If you withdraw, data collected up to that point may still be used to ensure the reliability of the study; no further study data will be collected unless you agree.
You may separately choose whether to allow left-over blood samples to be stored for future diabetes-related research and biomarker analysis. Declining does not affect your participation in the main study. (Separate signature below.)
I confirm that I have read and understood the information, have had the opportunity to ask questions, understand that participation is voluntary and that I may withdraw at any time, and agree to take part.
| Role | Name | Signature | Date |
|---|---|---|---|
| Participant | __________ | __________ | ____ |
| Person obtaining consent | __________ | __________ | ____ |
| (If applicable) Impartial witness / legal representative | __________ | __________ | ____ |
Optional future-research samples: ☐ I agree ☐ I do not agree — Signature: __________ Date: ____
Each participant receives a signed, dated copy. Region/site versions are localized and IRB/IEC-approved before use (ICH E6(R3) §4.8.10–4.8.11).