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AgendaHealthcareOnboarding & training

Site initiation visit (SIV)

180 minutes 15 blockspro Runs with Pro

A three-hour SIV that trains the site team on the protocol, consent, IP and safety reporting, with anonymous knowledge checks and log sign-off.

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Free to open and edit. Running it live needs Pro, free for 14 days on every new account.

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180 min · 15 blocks, drawn to scale Fits exactly
  1. Introductions: names, study roles and trial experience, 10 minutes 10
  2. Study overview: objectives, design and endpoints, 15 minutes 15
  3. Protocol walk-through: eligibility, visit schedule and procedures, 35 minutesInfo 35
  4. Knowledge check: eligibility, 3 minutes 3
  5. Informed consent: process, versions and documentation, 15 minutes 15
  6. Break, 10 minutes 10
  7. Investigational product: receipt, storage, dispensing and accountability, 15 minutes 15
  8. Safety reporting: AEs, SAEs and timelines, 15 minutes 15
  9. Knowledge check: safety reporting, 3 minutes 3
  10. Data: source documents, EDC entry and query timelines, 15 minutes 15
  11. Labs and samples: kits, processing and shipping, 10 minutes 10
  12. Investigator site file, monitoring plan and visit schedule, 10 minutes 10
  13. Training log and delegation log sign-off, 10 minutes 10
  14. Open questions, 9 minutes 9
  15. Actions before the site is activated, 5 minutes 5
04590135180 min
  1. +0′Introductions: names, study roles and trial experienceYour role on this study, in a few words?Tip: The answers tell you who is new to research, so you know where to slow down.10 minCheck-in
  2. +10′Study overview: objectives, design and endpoints15 minInfo
  3. +25′Protocol walk-through: eligibility, visit schedule and proceduresTip: Walk one imaginary participant from screening to the last visit. It surfaces practical questions better than reading the schedule of assessments.35 minInfo
  4. +60′Knowledge check: eligibilityA patient meets every inclusion criterion but also one exclusion. Can they enroll?Tip: Answer: No. Eligibility waivers aren't allowed; enrolling them would be a protocol deviation. Votes are anonymous, so people answer honestly.3 minVote
  5. +63′Informed consent: process, versions and documentationTip: Who may take consent (per the delegation log), using only the approved version, and documenting the process in the medical record.15 minInfo
  6. +78′Break10 minBreak
  7. +88′Investigational product: receipt, storage, dispensing and accountability15 minInfo
  8. +103′Safety reporting: AEs, SAEs and timelinesTip: Use the protocol's definitions and timelines. Many protocols require SAEs to reach the sponsor within 24 hours of the site becoming aware.15 minInfo
  9. +118′Knowledge check: safety reportingWhen does the clock start for reporting a serious adverse event?Tip: Answer: when any member of the site team first learns of it.3 minVote
  10. +121′Data: source documents, EDC entry and query timelines15 minInfo
  11. +136′Labs and samples: kits, processing and shipping10 minInfo
  12. +146′Investigator site file, monitoring plan and visit schedule10 minInfo
  13. +156′Training log and delegation log sign-offTip: Everyone who attended signs the training log. The PI delegates each task only to people trained for it.10 minDecide
  14. +166′Open questions9 minDiscuss
  15. +175′Actions before the site is activated5 minWrap-up

In short

A site initiation visit (SIV) is the meeting where the sponsor or CRO trains a trial site's team on the protocol before the first participant enrolls. This three-hour agenda covers the protocol, consent, investigational product, safety reporting and data, with two anonymous knowledge checks and sign-off of the training and delegation logs.
Time
3 hours
Blocks
15, with 2 knowledge checks
For
CRAs, PIs and site teams
Plan
Pro

Updated October 4, 2026

What's inside

By the end of this meeting, every site team member understands the protocol and their role, has passed the knowledge checks and signed the training and delegation logs. The full agenda is drawn to scale above: every block has its own timer when you run it live.

How to run it

  1. 1Send the agenda, protocol and slides a week ahead, and ask the PI to attend at least the overview, safety and sign-off blocks.
  2. 2Walk one imaginary participant through the protocol; it surfaces practical questions.
  3. 3Run the knowledge checks on phones. Votes are anonymous, so you see what the room really understood.
  4. 4Collect training and delegation log signatures before anyone leaves, and list the actions needed before activation.
  5. 5Send the summary to the site as the SIV follow-up, alongside your SIV report.

Questions people ask

What is covered at a site initiation visit?
Study objectives and design, the protocol, informed consent, investigational product handling, safety reporting, data entry, lab samples, the site file and monitoring plan, and sign-off of training and delegation logs.
What is the difference between an investigator meeting and a site initiation visit?
An investigator meeting trains investigators from many sites together, often before the trial starts. A site initiation visit trains one site's whole team at their own site.
Who should attend a site initiation visit?
The principal investigator, sub-investigators, study coordinators, the pharmacist and anyone else on the delegation log, such as lab staff.

Run it with your group

pro
  • A timer for every block on the shared screen
  • Results, decisions and actions in the summary
Use this template

Free to open and edit. Running it live needs Pro, free for 14 days on every new account.

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