You now have all the approvals in place - regulatory, ethics and any other local approval necessary to start the study. The sponsor (and this might be you!) will also have made arrangements for study intervention to be ready (delivered) to the site, or to arrive as soon as the first subject is screened. It is time to think about study initiation and a good way to check that everything is really ready is to take the whole team through every step and process of the study. The site initiation visit may happen a long time before the trial actually starts, so it is a good idea to have a further information session with all the staff just before study start, to ensure that the team is comfortable with the study procedures. However, if it’s more practical to combine the staff information sessions and study initiation, that would be perfectly acceptable: either way, you should document the training and who is present.

If this is a single-centre study then gather your team together to go through this process. If this is a multicentre study then it is important that each site does this to make sure everything is in place and has been thought about in realistic local practical sense.

The next step is to have all the study staff together and talk to them about the study. This should involve the principal investigator, the sub investigator(s), study pharmacist, study co-ordinator, field workers, research nurses, laboratory staff, data managers and data entry clerk(s), and any supporting staff that will be involved in the study.

A really good approach for this meeting is to try and ‘walk through’ the whole study in terms of sequence of events for the participants and then them and their samples and data. This session is very helpful for making sure you really have got everything in place and that an operating procedure written up for every step in which you need to make sure everyone can conduct the task the same way, every time, and according to the protocol.

With the team together, someone should lead a discussion that talks through the whole process for the study activities. For example this might start from the study team leaving the centre and driving to the clinic where they are recruiting (who is going, what do they need to take?) to then beginning screening, recruitment and enrolment. Talk through the detailed practical steps, which rooms, who is doing this – are they trained. Do you have the right forms prepared? Is there an SOP? What happens next – perhaps a blood sample is taken. How is it labelled and packed and transported back to the laboratory? How quickly? Now you need to probably have two branches of ‘walking’ through the process. One that follows the sample and one that carries on with the participant. It is really helpful to have everyone involved in the whole study listening in and contributing to this walk through. This is because even if they are not involved in that specific step, it will help if they understand what is happening in the whole study. Continue this process right through all the visits making sure you are thinking about the practical who, what and where with each process. Write check lists and notes to make sure you have covered every step.

At this visit (or the initiation visit if this is separate) someone, such as the monitor (if you have one) or study coordinator should go through the study documentation to ensure that the key essential documents are in place. For example they will ensure that the laboratory is set up and that the materials and equipment is in place, and ensure the study staff are familiar with the appropriate kits to be used for each assessment in the protocol. Also, if there are any electronic patient reported outcome (ePRO) devices or study specific devices that the study staff require for data capture, the monitor will ensure that sites are proficient in using the device. The monitor will also advise sites of the timeliness in which data should be entered in the electronic clinical research form (eCRF) and the time frame for query resolution.

If there is site equipment that needs to be used for the study, it will need to be checked and calibrated, and this should be recorded.

There should also be a dedicated room for patient visits, and sites should be aware of the consenting process.

Lastly, the visit will also be a good opportunity to remind sites of their recruitment goals/commitment and also to provide site staff with the contact details of key personnel able to assist sites with questions pertaining to the study.

Once the study staff are comfortable with the study requirements and what needs to be done, they are ready to start the study. However, they may still need hand holding – especially if it is a multicentre study. The identification and enrolment of their first patients to the study is the most difficult step for research staff and so they should be well supported. For multi-centre studies in particular, sites should therefore not be left alone after the information sessions. They should be encouraged to stay in regular contact with the coordinator, if you have one, and vice versa the coordinator should regularly contact them to ensure that sites are actively seeking subjects. Sites may be involved in other similar studies and keeping in touch with them will help keep the study at the forefront of the site team’s minds. It will also help uncover any issues sites may be facing with enrolment such as difficulty in identifying potential subjects or just getting started with a new study.