📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

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.

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About this document — a plain-language guide

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

Informed Consent Form (ICF) — GLPI103-301 (master template)

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

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.

Change History

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

Introduction

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.

1. Why is this study being done?

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.

2. Why have I been invited?

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.

3. Do I have to take part?

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.

4. What will happen to me?

The study lasts about 58 weeks: a 2-week screening period, 52 weeks of treatment, and a 4-week follow-up.
You will be placed by chance (like flipping a coin, a 1-in-3 chance for each group) into one of three groups. Neither you nor your study doctor will know which group you are in (this is called "blinding") because it gives the most reliable answer.
Because the medicines are given in different ways (an injection and a tablet), everyone receives one weekly injection and one daily tablet — one of these is the real medicine and the other is a dummy ("placebo") with no active drug. This is called a "double-dummy" design.
The dose is increased slowly over the first weeks ("titration") to reduce stomach side-effects.
You will keep taking your metformin. You will come to the clinic at scheduled visits for blood tests (including HbA1c), weight, blood pressure, and checks on how you are feeling (see the visit schedule).

5. What are the possible risks and side-effects?

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.

6. What are the possible benefits?

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.

7. What are my alternatives?

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.

8. Will my taking part be kept confidential?

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).

9. What if there is a problem or I am harmed?

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.

10. Voluntary participation and withdrawal

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.

11. Optional sub-study (biomarker / future research)

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.)

12. Contacts

Study doctor / site: __________________ Tel: __________
Ethics committee (IRB/IEC): __________________ Tel: __________
24-hour medical contact: __________________

13. Statement of Consent (signatures)

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).