Clinical Trial Consent and Participant Videos from Approved Documents

The direct answer: Make complex study participation easier to explain across sites and languages, from the documents your team has already approved. Golpo is the production workflow. Start from the approved visit calendar, the diary guide, the contact card, or an exact script when the wording is already approved. Golpo drafts narration in Prompt Mode where you want a draft, plans the scenes, and outputs the video. Edit script before creating video is the checkpoint before the render. Script Mode is there when the approved consent sentence has to be spoken as written.

This guide is for research sponsors, sites, CROs, IRBs, participant-engagement teams, and study operations leaders. Start with a visit map or a diary explanation. Consent media, when you produce it, stays inside the study's layered review and still supplements the consent conversation. The four videos below were each generated in Golpo from the document beside them. For those four renders, no narration script was supplied. You can open the PDF, read the brief, and compare the finished video with both. When the wording is already approved, paste it in Script Mode.

What participants need before the next visit

• A calendar, a diary window, and a contact card are easier to follow as pictures than as dense attachments, and participants still need the approved document.
• Two sites can share one explanation and still differ in the few fields the protocol allows: the address, the local phone, the coordinator.
• The next cohort, and the next language, should start from the same approved source version, with a new review when that version changes.
• A completed view is not a measure of comprehension. The study's own process assesses understanding.

The four examples keep the jobs separate: key information from the consent, the visit calendar, the study diary, and who to contact. Pilot the calendar or the diary. Use the consent example as the pattern for a supplemental key-information video, with exact wording available through Script Mode and with ethics review still in your process.

Four real document-to-video examples

Build this video entirely from the attached document. Title it: The Key Information in This Research Consent. Explain the consent's purpose, voluntary nature, procedures, risks, alternatives, privacy section, costs, and contacts. Write the narration yourself from the attached document. No narration script has been supplied. Do not introduce any fact, figure, date, name, instruction, recommendation, legal conclusion, clinical interpretation, benefit, or outcome that is not in the document. Do not soften or strengthen its wording. The document is a clearly labelled fictional specimen, so describe its organizations, people, identifiers, and values as illustrative rather than real.

Keep the consent's headings and approved wording visible. State that the video supplements but never replaces consent discussion or the signed form. FIGURE LOCK: every number, date, identifier, threshold, amount, dose, score, time, temperature, visit window, phone number, and code shown or spoken must be copied from the attached document. Never invent a placeholder or rounded value.

Build this video entirely from the attached document. Title it: Your Research Visit Calendar. Explain screening, baseline, treatment visits, phone checks, windows, fasting flags, specimens, and reimbursement records. Write the narration yourself from the attached document. No narration script has been supplied. Do not introduce any fact, figure, date, name, instruction, recommendation, legal conclusion, clinical interpretation, benefit, or outcome that is not in the document. Do not soften or strengthen its wording. The document is a clearly labelled fictional specimen, so describe its organizations, people, identifiers, and values as illustrative rather than real.

Build the schedule as a calendar using every visit window exactly as printed. Never infer eligibility. FIGURE LOCK: every number, date, identifier, threshold, amount, dose, score, time, temperature, visit window, phone number, and code shown or spoken must be copied from the attached document. Never invent a placeholder or rounded value.

Build this video entirely from the attached document. Title it: Completing the Study Diary. Explain activation, daily entry window, missed entries, corrections, device sync, travel, and support. Write the narration yourself from the attached document. No narration script has been supplied. Do not introduce any fact, figure, date, name, instruction, recommendation, legal conclusion, clinical interpretation, benefit, or outcome that is not in the document. Do not soften or strengthen its wording. The document is a clearly labelled fictional specimen, so describe its organizations, people, identifiers, and values as illustrative rather than real.

Animate the actual screens described by the guide and preserve every timing window. Do not suggest backfilling. FIGURE LOCK: every number, date, identifier, threshold, amount, dose, score, time, temperature, visit window, phone number, and code shown or spoken must be copied from the attached document. Never invent a placeholder or rounded value.

Build this video entirely from the attached document. Title it: When and How to Contact the Study Team. Explain the routine, urgent, and emergency contact routes, what information to have ready, wallet-card use, and reporting log. Write the narration yourself from the attached document. No narration script has been supplied. Do not introduce any fact, figure, date, name, instruction, recommendation, legal conclusion, clinical interpretation, benefit, or outcome that is not in the document. Do not soften or strengthen its wording. The document is a clearly labelled fictional specimen, so describe its organizations, people, identifiers, and values as illustrative rather than real.

Use the three urgency lanes exactly. Do not diagnose an event or imply the study team replaces emergency services. FIGURE LOCK: every number, date, identifier, threshold, amount, dose, score, time, temperature, visit window, phone number, and code shown or spoken must be copied from the attached document. Never invent a placeholder or rounded value.

The controls for a library sites can reuse

The same approved calendar can become a site-specific visit video, then a diary video in the study's visual style, then a reviewed language variant. The four videos are the document drafts. The second site, the real diary screens, and the version record are the production steps around them. Plan gates are on pricing.

• Draft the visit explanation from the calendar. In Prompt Mode, upload the approved schedule and let Golpo write the narration. You review it before the render. The upload does not certify visit windows or version identifiers.
• Script Mode when the words are already approved. Paste the approved narration, including consent wording that must be spoken as written. About 1,050 characters correspond to a selected minute. Put visual directions in Video Instructions, not in the spoken script. In the API, custom_script supplies narration. enable_script_only_mode is script-generation-only, not a request to render an exact script.
• On-screen text from the script. On Canvas and Sketch, generated labels stay inside the script source. Golpo may show a subset of the words. Use it for visit windows, diary times, and version identifiers that must not pick up outside wording. It is not a caption track, and it does not verify the source. See on-screen text from the script. In the API, set onscreen_text_from_script_only explicitly.
• Custom Scenes for each diary action. Give activation, the daily entry window, a missed entry, a correction, and device sync their own scenes, within the engine limit. The map does not rewrite the narration. Custom Scenes is on Growth and higher.
• The actual ePRO screens. The diary video animates the steps described in the guide. A generated phone is a diagram. Insert authorized stills of the real diary interface with Own Media, on Business and higher, with no participant entries visible. Participants should see the buttons they will tap.
• A study style and a known coordinator. Save a named Custom Style from an approved visual reference under My Styles, and reuse it across the visit video, the diary video, and the next cohort. Custom Style is on Business and higher. API use also needs API access. It is inspiration, not pixel-exact branding or exact typography. With permission, a coordinator can record the visit explanation. Own Narration builds the visuals from that recording, and Picture-in-Picture keeps the coordinator visible. The recording sets duration and spoken language. A language setting does not translate that audio. Voice Instructions apply to generated narration, not to the recording. Own Narration and Picture-in-Picture are on Business and higher.
• Layout for the job. The visit-calendar example uses Canvas Illustration Compact, so the schedule stays together. The consent example uses Editorial Expanded, so each section has room. Compact groups components. Expanded spreads them. See Compact and Expanded.
• A language library. Each additional language is a separate render. Use language_variants in the API when you generate them that way. Have a reviewer who can check the terminology, dates, and version id. Creator and higher include multilingual features. Starter has a language add-on. More than 45 languages are listed.

Workflow: one calendar, a second site, one correction

Build the visit explanation participants need before the next enrollment cohort. Example 2 is the document draft from a specimen calendar. A second site, with only authorized fields changed, is the reuse you run from that approved file.

1. Source. Freeze the approved calendar version. Note the version id in your trial system. For a second site, change only the fields the site supplement authorizes, such as site name, address, and local contact. Leave procedures and windows as the approved calendar states them unless that supplement amends them.
2. Settings. Prompt Mode to draft the visit explanation, or Script Mode if the narration is already approved. Custom Scenes on the diary video so each action has its own scene. Own Media for the real ePRO stills. Custom Style for the study. An authorized coordinator recording if the site wants a familiar voice and face. On-screen text from the script for windows and version labels.
3. Script review. Use Edit script before creating video. Read windows, fasting flags, contacts, and the version id against the open calendar. Write the reviewer, the date, the source version, and the render id into the trial file. That record is yours. Golpo does not store the ethics approval.
4. Result. Watch the render beside the calendar. The four videos on this page are finished document drafts, at 2:17, 2:16, 2:13, and 2:10.
5. One correction. Here is the hypothetical correction. A frame shows a visit window that is not the window on the approved calendar, and the spoken line is already right. Frame-edit the label. The first edited version is free across sessions until finalized. Frame editing is on all paid plans, and later versions are charged on the selected duration of that version. It does not change the narration. If the spoken window is wrong, correct the script and render again.
6. One reuse. Render the second site from the same approved calendar, changing only authorized fields, and review it as a new asset. A later cohort reuses the style and the scene map. If the calendar version changes, render from the new approved file. A language variant is another reviewed render, not a translation of a coordinator's recording.

Plan, duration, and credits

A standard video uses 1 credit per selected minute. The four examples run 2:17, 2:16, 2:13, and 2:10. This page does not list the selected-minute setting or the credit total for those renders. A three-minute selection is 3 credits at the standard rate. A second site is another render. A later frame edit and a language variant are additional charges on their own selected durations. Own Narration uses the standard rate. The recording sets the length.

• Prompt Mode, Script Mode, and script review are part of the core workflow. Length limits vary by plan. You can download Golpo's free 1-minute video without a watermark for $9.99, or subscribe to download it at no extra charge.
• Custom Scenes: Growth and higher. Color begins at Growth.
• Custom Style, Own Media, Own Narration and Picture-in-Picture: Business and higher. Frame editing: all paid plans.
• Multilingual variants: Creator and higher, with a language add-on on Starter.

Current prices and duration limits are on video.golpoai.com/pricing.

What stays outside Golpo

IRB or ethics approval, the trial master file, source-version history, site distribution, and withdrawal of an outdated video are your systems. A video does not document informed consent. A completed view does not establish comprehension. The Golpo API can request a render from an approved file and report status. Scale includes API access. Business has a paid API add-on. API Only is a separate product with its own metering, and it does not include dashboard generation. An API call does not grant ethics approval or choose which version a participant sees. Presenter generation through the API is still described as coming soon and is not part of this workflow.

One review checklist

• The render matches the named source version. Windows, contacts, fasting flags, and version identifiers match the approved file. A line in the visual direction that tells Golpo to copy figures is a prompt instruction. You still compare the video with the calendar.
• Site variants change only authorized fields. Procedures and risks stay as the approved source states them.
• Consent wording that must be exact was supplied in Script Mode and read back before the render.
• Diary screens that must show the real product are authorized stills, with no participant data. A generated phone is a diagram of the steps.
• The video supplements the consent conversation. It does not replace discussion, voluntary choice, or the signed form.
• A completed view is not recorded as comprehension, eligibility, or adherence.
• Urgent events follow the contact card, including emergency services where the document says so. The video does not classify an event.
• Captions and the transcript belong to the player you ship. The review record names the reviewer, the source version, the render, and the date, in the trial system that owns that record.
• If the video and the document disagree, participants receive the document's version.

Authority sources

• FDA Informed Consent Guidance
• FDA/OHRP Electronic Informed Consent Q&A
• ICH E6(R3) Good Clinical Practice
• NIH clinical trial protocol template

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• Automate video generation with the Golpo API
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Frequently asked questions

Can video replace the consent conversation?

No. A video can walk through key information, a visit calendar, a diary, or contact routes. It does not replace discussion, questions, voluntary choice, or the signed approved form. It is not informed consent, and it is not IRB approval.

Does watching prove understanding?

No. A completed view does not establish comprehension, eligibility, enrollment, or adherence. Understanding is assessed through the study's approved process.

Can we supply the exact approved consent wording?

Yes. Use Prompt Mode when Golpo should draft a visit or diary explanation from the approved document. Use Script Mode when the narration must be the approved consent wording, then approve that script before rendering. The consent example on this page was drafted from the document, with no script supplied.

How do two sites share one visit explanation?

Start from the same approved calendar. Change only the fields the site supplement authorizes, such as site name, address, and local contact. Render each site separately, review each render, and record the source version in your trial system. Golpo does not store the ethics approval or remove the previous file from a participant portal.

Who approves the final video?

Follow the protocol and the sponsor, site, legal, and IRB or ethics-committee requirements that apply to participant-facing audiovisual material. The review record lives in your trial file.

What happens after an amendment?

Render again from the newly approved source, review the new video, and record the new version. Remove the outdated video from participant access in the system that distributes it. Keep the version history there.

Can the video report adverse events?

No. It can explain the contact routes printed on the approved card. Participants use that process, or emergency services when the document says to.

Create the visit or diary video before the next enrollment cohort

Pick the diary or the visit map participants will need before the next cohort is enrolled. Generate it in Golpo from the approved calendar or diary guide, review the windows against that file, and record the source version in your trial system. When a second site needs the same explanation, render it again and change only the fields that site is authorized to change.

Create the visit video in Golpo. Confirm Custom Scenes, Own Media, and Custom Style against your plan on pricing.