Today's post comes from Ashley Smith. She is GxP Editor at Whitehall Training, a leading supplier of online training courses for the pharmaceutical sector. He is a regular blogger and is particularly interested in the subjects of pharmacovigilance, GCP and GDP.
Good Clinical Practice (as set out by the International Committee on Harmonisation) covers all aspects of clinical trials – from recruiting patients to analyzing results. With recent well-publicized moves towards full disclosure of trials data, it is a good time to look at what GCP guidance says about correct handling of data.
During the course of a trial, data flows from the investigator to the sponsor. At each stage, data must be checked and there need to be systems that ensure that data transfer is accurate and complete.
Where changes have to be made to correct or explain data, they should always be done by following written standard operating procedures and there should be an audit trail. Where data is stored, systems need to be in place to ensure that the storage is secure, both against tampering and natural disaster.
The CRF and source documents…
Source documents are original documents, data and records plus certified copies or transcriptions. They may include x-rays, hospital reports, patient details etc.
The Case Record File (CRF) is the document designed to enable data to be passed accurately from the trial to the trial’s sponsor. The investigator in charge of the trial must complete the CRF. The sponsor will appoint a monitor who checks that the information on the CRF is complete, accurate and supported by source documents. The source documents themselves must also be accurate, complete and up-to-date.
When corrections are made to the CRF, the original entry must not be obliterated and all changes should be dated, initialled and explained. Only those staff who have been given this role by the investigator should make changes to the CRF.
The sponsor has overall responsibility for the trial and should have robust systems in place to review all data on their product as soon as possible and communicate these data promptly to all concerned – investigators, institutions, and the relevant regulatory bodies.
Serious side-effects must be reported promptly. But the sponsor’s role does not end there. They must evaluate on-going safety data and provide reports to the investigator and the authorities at pre-specified intervals. In the EU these reports are required annually on the anniversary of the first approval of a trial involving the test drug in the country.
The Investigator Brochure…
The second document specified by GCP rules is the Investigator Brochure. The IB is the handbook for a test drug. It should contain all of the background safety and efficacy data (including pre-clinical data) that will allow an investigator or other clinician to make an informed judgement regarding the risk balance of a trial. It is core to GCP that no trial is undertaken until foreseeable risks and inconveniences are weighed against anticipated benefits and the benefit justifies risk.
After the trial finishes…
Sponsor documentation must be kept for two years following either formal discontinuation of the clinical development of the drug being tested or following the final marketing approval in a region governed by the ICH rules. There are exceptions…
Some regulatory authorities demand longer storage – for example, the holding period is five years in the EU. In practical terms, regulatory authorities generally require longer storage times and it is always wise to seek specialist advice before destroying the sponsor’s files!
All of this guidance is contained in the online GCP courses offered by Whitehall Training. They offer courses in English as well as Bulgarian, French, German, Japanese, Polish, Portuguese, Russian and Spanish. Their courses have been used by over 20,000 learners – making them by far the most popular online course available.
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