SOPs are as defined by the International Conference of Harmonisation as ‘a detailed written instruction to achieve uniformity of the performance of a specific function’ (ICH GCP 1.55). Some studies use a manual of operations which is where the SOPs are collected into a handbook. In brief, SOPs translate the protocol into meaningful and detailed instruction that are written, ideally by those who will be carrying out the step begin described, specifically for each study site.
They are also extremely useful for auditing and monitoring purposes, and to ensure consistency across sites.

Standard Operating Procedures
SOPs are guides for the clinical research team on how various processes involved in setting-up, maintaining and running clinical trials should be followed, so that the protocol is followed accurately and consistently and that any regulatory requirements are met. SOPs should therefore be easy to follow and written descriptively enough to ensure that there are no variations once implemented.

SOPs should be standardised across an establishment and therefore the same format and layout should be used across all the SOPs.
Typically the starting point in writing a SOP would be for all the team tasked with conducting a step to get together and talk through exactly what will happen, i.e. who will do what, when and where in order for the step to be accurately completed.

The SOP should also have a date of initial approval, the effective date, definition of abbreviations, date of next revision, schematic or flow chart diagram to aid understanding if that will help. An example of tables, forms or template can be added as appendixes at the end of SOPs as well. It is also important to reference the applicable guidelines and regulations within the SOP such as ICH GCP, the EU directive or the appropriate FDA guideline.

There should also be a process for the periodic review of SOPs which should take place at regular frequency depending on the length of the study and whether any concerns arise.

Many establishments will have an electronic template of the structure, format and layout so that whoever needs to write the SOP can download the template and make the appropriate updates or changes, rather than having to start from scratch. You can download some template SOPs which can be adapted for other study types here. 

Advantages of using SOPs during clinical research
- SOPs help to ensure a more practical and meaningful interpretation of GCP, and documents and enhances learning for the investigator and the study team.
- It demonstrates to sponsors, auditors and inspectors that the site is committed to implementing GCP.
- SOPs will reduce system variation, which is the enemy of efficiency and quality control.
- SOPs facilitate training since having complete step-by-step instructions helps trainers ensure nothing is missed and provides a reference resource for trainees.
- Well-written SOPs facilitate cross training. SOPs can be an excellent reference document on how a task should be performed by study staff filling in on jobs they do not perform on a regular basis.
- Study staff can coach and support each other if there is documentation available on exactly how various tasks must be done and everyone knows what the rest of the team are supposed to be doing. This can also help generate a more cooperative team approach to getting all the daily tasks done correctly, consistently.

SOP Training
There is no point having the appropriate SOPs in place without adequate training in how to implement them. All staff should be trained on the SOPs and a record of their training documented by the research institution. Training will need to be consistently delivered to all team to ensure there is no misinterpretation of the SOPs. Training over the years has improved and can be taken in a number of ways such as classroom based training; computer based training or self reading. The choice of training will depend on the type of SOP and the structure of the institution.

Computer based training and self read training represents a cost effective way of training staff on SOPs and this method has widely been adopted by many research institutions. It offers the advantage of being able to train staff at multiple locations in a consistent and cost effective manner. The timing of delivery is very quick and can be tracked electronically with date and time stamp.

Computer based training can be used for more cumbersome SOPs or where staff need to be trained on new electronic systems. The training tends to include computer based test to assess users understanding of the SOP. One of the advantages of this training is that it doesn’t have to be completed all at once thereby offering some flexibility in training.

Classroom based training on the other hand are rigid and are becoming rare for the sole reason of the time, resources and cost required in delivering training. Often this type of training is conducted along with any other company training, such as staff induction.

As well as training staff on SOPs it is necessary to check compliance to the SOPs and it is important that users adhere to the relevant SOPs.

Distribution of SOPs
SOPs are controlled document and needs to be monitored and controlled so that it is clear which version of the SOP is current. Ideally there should be someone or a department (depending on the size of the establishment) responsible for controlling the documents as well as ensuring that superseded SOPs are removed and replaced with the current version. They will periodically update the SOPs on the anniversary of their renewal.
It should be clear where the current SOPs are filed either as paper or electronic copies so that there is no doubt as to which SOPs are current.
The institutional intranet/intranet site is a popular area to file SOPs but this will need to be controlled with proper audit trails so that only those who have the authority to update the document can update them.

Any process that needs to be followed in a uniform manner will need a SOP. Some of the tasks within clinical research that requires SOPs includes:

- Data Management
- Protocol writing and any amendments
- Site pre-study, initiation, monitoring and close out visits
- Regulatory authority and EC submission processes
- Delegation of authority
- Sample collection, transportation, logging
- Case record form completion
- Measuring or assessment of key endpoints data (i.e. measuring upper arm circumference) to ensure consistency
- Drug/device/intervention storage, accountability and management
- Informed Consent process
- Adverse Event and Serious Adverse Event reporting

Conclusion
Writing SOPs can seem daunting especially if they are being developed for the first time. ‘Walking’ through the step as a team really helps highlight the areas where the method or particular delegations need to be decided and recorded. It may not be possible to pre-empt all the clinical research tasks for which SOPs are required, but as with most tasks, it is probably best to start with those SOPs that are obvious. As more tasks are identified, additional SOPs should be written to cover those tasks.

References
Mandy Vicks “SOP writing for Clinical Research”
https://www.iths.org/wp-content/uploads/ITHS-SOPs-for-Clinical-Research-03-03-10.pdf 

The Centre for Clinical and Translational Science “Writing Standard Operating systems” Ohio State University
http://ccts.osu.edu/education-and-training-programs/research-education-and-training-programs/clinical-research-coordinator-resources/writing-standard-operating-procedures-sops