Your first study
You create a draft, finish the ten ready steps, and launch. Launching creates the rounds. It does not send an invitation.
This path is for a person who will be the principal investigator of a new study. A coordinator who did not create the study uses the short note below and then the invitation guides, not a second copy of this path. A methodologist starts at Consensus analytics, not here.
What you will have at the end
A study that is past draft, with round 1 still to be approved and opened, and with no invitation sent by the launch itself. Later sections say what inviting, opening, closing, deciding, completing, and exporting look like. Each of those is a separate task.
Before you start
You need permission to create a study. Creating it makes you the principal investigator.
Read Study team before anyone confirms what the rules decided, adds or removes a role, or completes the study. The screen names who may do each of those things. This page does not.
If you are the coordinator
You can run the contact steps, and you can open or close collection after a valid principal-investigator approval. You can download the pseudonymized panelist list. You do not launch the study, compute results, download the study-report files or the identifiable exports, or complete the study. Start from Study team. Adding people and sending messages are the signed-in Help articles Panelists and Invitations. Sign in, then open Help & docs in the account menu.
The example
The study in this page is synthetic. Call it the Handoff statements study. A small research team wants clinicians to rate short statements about shift handoff. Nobody in the example is a real participant, and the statements are not from a patient record. Use it to recognize the stages. Use your own protocol for the real wording.
1. Create the draft
Creating a draft does not launch the study and does not send an invitation. The new study is listed under Drafts.
Follow Start a new study. Stop when the study exists and has not been launched.
Checkpoint. The study is under Drafts. No invitation has gone out.
2. Finish the ten ready steps
Setup is eleven screens. Ten count toward ready. Review & launch is the eleventh screen and is not one of the ten.
The ten ready screens, in the order the study uses, are:
- Identity
- Method
- Eligibility
- Size & mix
- Profile & integrity
- Item bank
- Rating & consensus
- Rounds & feedback
- Consent & comms
- Analysis plan
Review & launch is the eleventh screen. The ten screens sit in four groups:
Follow that order. Do not follow the staff-guide sidebar order. That order is provisional and starts at a different article.
A public study page can be added under Consent & comms. It is optional, and it is not one of the ten ready steps. Study team can also block launch. It is not one of the ten.
On Rating & consensus you choose the study's own rule. The values a new study starts from are on Consensus analytics. They are not a universal standard. This page does not define them. Stability can be switched on there. Nothing computes it.
Checkpoint. Review & launch shows how many of the ten steps count as ready. A step marked Needs attention still counts. A step marked Blocks launch does not. A step marked Required later does not. A Study team error also refuses launch.
3. Check readiness and launch
Launch comes after the draft. It sends no invitation. It cannot be undone.
Only a draft whose ten ready steps count as ready can launch, and only a person who may edit Setup can launch it. That edit permission belongs to the principal investigator. Launch is also refused while a Study team error is open, while the round plan is empty, or while counted groups cannot meet the Round 1 group check until those targets are explicitly acknowledged.
The button on Review & launch is Launch study, under the heading Launch this study. The confirmation control is Launch. The card states that no invitation is sent.
Use Review and launch for that screen. What the server then freezes, and what an amendment can still change, is Governed study record. This tutorial does not copy either list.
Checkpoint. The study is listed under Active. The rounds from the saved plan exist. Round 1 has not been opened by the launch. No invitation was sent by the launch.
4. Invite, enroll, approve, and open
You have reached this page's outcome when section 3's checkpoint is true. The stages from here on are the map for later. Each one is its own task. Do not treat them as part of creating the draft or of launching.
A queued invitation is not delivery and not enrollment. Opening a round is not launch.
Invitations and enrollment
Add people and choose whom to invite. Enroll a person only when that person's record allows it. When screening is on, record eligibility first. When the study requires consent before enrollment, record consent first. Those screens are the signed-in Help articles Panelists, Invitations, and Enrolling after consent. Sign in, then open Help & docs in the account menu.
Checkpoint. The Delivery ledger, not the queue alone, shows whether an invitation was delivered. An enrolled person is not the same as an invited person.
Approval, opening, collection, and closing
Whoever opens the round, a valid principal-investigator approval comes first. A coordinator may open or close collection after that approval. Opening sets that round's panel. If the study allows a later addition by approval, the screen says an investigator can include someone after that, with a recorded reason. Otherwise a person who becomes eligible after opening waits for a later round. If the study is set to tell people the round is open, opening can queue that message. That message is not the invitation you send from Panelists.
Collection is the time panelists rate. Results are not computed while collection is open. Closing collection ends rating for that round. The screen steps are in the signed-in Help article Rating rounds. Sign in, then open Help & docs in the account menu.
Checkpoint. The round shows open only after approval. It shows collection closed only after that later step. Do not treat a queued message as proof that either step finished.
5. Results, later rounds, completion, and the report
Review the results
After collection closes, someone who can edit Results chooses Compute results. The principal investigator, the steering committee role, and the biostatistics role can. A coordinator cannot. A steering member who only confirms can read results and cannot compute them. When the action finishes, a results version is listed, or the screen says why it was not.
Computing stores a sealed results version. It does not decide the round. Stability, a subgroup comparison, a rating mean, and a standard deviation are not results. No step on this path asks you to approve generated text.
Read the class and the measures on Consensus analytics. Read what to do with a result on Interpreting results.
Checkpoint. A results version exists, or the screen says why it does not. The screen states how many people submitted, how many were counted, and how many were left out.
Researcher decisions and a later round
Read Study team before anyone confirms what the rules decided. A new study starts with the principal investigator or the biostatistics role able to confirm. The study can keep those duties apart, and the protocol rule set requires that. The screen then names who may confirm. Do not assume the principal investigator is always excluded, or always included.
A later round, when the plan has one, is prepared, approved, and opened on its own. It is not opened by launch or by computing results. Adding a round that was not in the launched plan is a recorded amendment, described on Governed study record. The new round is still approved and opened by hand.
Checkpoint. Each statement has a decision the screen will show you, or a reason it is not ready. A further round exists only if the plan or a recorded amendment created it, and it is open only after its own approval.
Complete the study
Completing a study is one-way, and only the principal investigator can do it. The button that opens the confirmation is Complete this study…. The heading is Complete this study now? and the confirm control is Yes, complete the study. Setup becomes read-only. Reporting can still be read and downloaded. An approved removal writes a new results version. Retention and deletion requests stay on the Completion page. Follow Completion and retention.
Checkpoint. The study is under Completed, or the screen still names a reason it cannot be completed. Do not complete a study to finish a single round.
Export and reporting
The files you can download are named on Reporting. They support a manuscript. They are not one. Ordinary study-report files are not the same as the identifiable downloads on Governed study record.
Checkpoint. You downloaded the file the reporting guide names for the question you are answering, and you can say whether that file is a study report or an identifiable export.
If the path stops
Stay on the how-to for the step that stopped.
| What stopped | Open |
|---|---|
| The draft does not exist | Start a new study |
| A ready step is unfinished | The setup guide for that group, above |
| Launch is refused | Review and launch and Study team |
| An invitation was not delivered | Sign in, then open Help & docs, article Invitations. |
| The round will not open | Sign in, then open Help & docs, article Rating rounds. |
| The result is hard to read | Interpreting results |
Next step
When section 3's checkpoint is true, sign in and open Help & docs, then the article Invitations. Round 1 is still to be approved and opened.