Data collection

Once you have all your approvals, your sites agreed and set-up and have started to recruit patients you can now start collecting the data for your study. Your data collection materials should have been designed up front however there are a number of considerations you should take into account:

• Confidentiality and Data Protection
• Recording Data
• Data Storage Requirements
• Study Amendments
• Progress Reporting

Confidentiality & Data Protection

It must be made clear to participants in the information provided to them when they decide whether to take part in the study, what data will be collected from them, who will have access to this, and what safeguards are in place to ensure confidentiality. If you wish to collect information from participants medical records, this must be explicit in the information sheet and consent specifically granted for this, especially where the patient is being seen for the study at one site but where you wish to access notes from their GP or other site. You would usually be expected to supply a copy of the signed consent form to the GP practice or site before they will release information from patients medical records for research. Please see access to patient notes guidance note issued by NHS Norfolk.

Where sites are referring into a study being conducted elsewhere you should make sure you notify the referring site that one of their patients have been recruited.

Where information needs to be collected and transferred from one site to another (for example provision of medical history from a GP to the research team) you need to consider how this can be transferred and ensure that this meets PCT guidelines for the transfer of participant identifiable information. Further information can be obtained from the R&D Office at NHS Norfolk.

Recording Data

Data collected for the purposes of research should be recorded in a manner which ensures there is a complete audit trail. For these purposes all original data should be recorded in ink and any errors corrected with a single line through the error such that the original error can be seen, initialled and dated with a reason for the correction given if applicable. E.g.

Data Storage

All documentation pertaining to a research proposal needs to be retained until, and often beyond the end of the study (see study archiving section for more details on retention periods). The “essential documents” that need to be maintained are those which:

Enable both the conduct... and the quality of the data to be produced to be evaluated;
and
Show whether the trial is, or has been, conducted in accordance with the applicable <regulatory> requirements...
The Medicines for Human Use (Clinical Trials) Amendments Regulations 2006

Although only a legal requirement for clinical trials which fall under the EU Clinical Trials Directive it is good practice to maintain a similar set of documents for all other research.

It is the Sponsor's responsibility for maintaining a Trial Master File for the project (although this responsibility may be delegated in part to the Chief Investigator or Principal Investigator) containing the essential documents. This must be complete and legible, and available for inspection or audit by the relevant authorities including the host PCT/Trust. Storage of documents must be secure with access restricted to limited personnel, and where identifiable personal data is involved (e.g. consent forms, questionnaires with names and addresses, participant notes) must be stored and transferred to relevant parties in accordance with the Data Protection Act.

A list of the essential documents for a trial can be found in Section 8 of the ICH-Good Clinical Practice Guidelines. Any alteration to these documents must be traceable, this is a requirement of the UK legislation on the conduct of clinical trials.

Study Amendments

All amendments made to your study (including addition of personnel, extension of timelines, changes to study documentation etc) will need to be notified and/or approved by the bodies who originally approved your study – please see Amendment section for more details.

Progress Reporting

You are usually required to report the following to the bodies which originally approved your study:

• Serious Adverse Events
• Incidents / Complaints
• Annual Progress Reports
• End of Study Reports

Further details can be found in the Post Approval Section.