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dot Staff Training for CTIMPs dot RD Direct Learning Courses
dot Development of Staff Training Records dot LTHT/UoL Training Courses
dot Content of Staff Training Records dot GCP Training
dot Maintenance of Staff Training Records  
dot Retention of Records  
   


Staff Training for CTIMPs

As directed by ICH Good Clinical Practice Guidelines, it is required that Investigators working on a CTIMP are qualified by training and experience to undertake their relevant roles and responsibilities. It is also the responsibility of the Investigator to ensure that appropriately qualified members of staff are available to work on the CTIMP.

A record of the members of staff working on a clinical trial is kept within the Trial Master File, using the sponsor approved Staff Authorisation and Responsibilities List.

A record of the relevant training for each member of staff undertaking work on a clinical trial must also be kept, in line with the Staff Training Record SOP .

The following sections are taken directly from the Staff Training Record SOP:

Development of Staff Training Records

    1. It is the responsibility of the individual member of staff to create and maintain their own training file.
    2. For members of staff already working on CTIMPs: all members of staff must have a training file created within 2 months of  the effective date of this SOP.
    3. For new members of staff: all members of staff must have a training file created within 2 months of their start date.
    4. The staff training record forms a paper record of education, training, qualifications and experience for each member of staff working on CTIMPs.
    5. It is permitted that a central staff training record may be developed within a department rather than on a per person basis. The content of such a file remains the  same as that for an individual staff training record.
Back to CTIMP Page

Content of Staff Training Records

    1. Curriculum Vitae (CV): Current CV, signed and dated by the relevant individual, containing evidence of education, training, qualifications and experience with specific reference to clinical trials
    2. Job description: Current job description. Any previous job descriptions and dates in position relevant to clinical research, if not detailed in the CV.
    3. Training Record Log: Cumulative list of external and internal training received whilst in post with specific reference to training undertaken which enables the individual to competently perform their job and duties delegated to them in a clinical trial. Standard Template CTC04.
    4. Certificates of course attendance and agenda of courses/meetings: These may be photocopies or originals
    5. Details of any relevant training conducted prior to appointment, which is not listed in the current CV.

Maintenance of Training Records

    1. Curriculum Vitae: Update in line with the current Sponsor approved CV Work Instruction .
    2. Job description: An up to date version must be saved in the staff training record if any changes are made to it.
    3. Training Record Log: The training log may be maintained in a paper or electronic format. If maintained in an electronic format it must be printed at a minimum annually, signed by the individual member of staff to which it relates and filed within the staff training record
    4. Certificates of course attendance and agenda of courses/meetings: New certificates and agendas filed on an ongoing basis.

Retention of Records

    1. When a member of staff leaves their post within the department the Chief Investigator will ensure that a photocopy of all documents contained within the individual's staff record file is made and retained within the department. Such records must be archived in line with the current Sponsor for CTIMP Archiving Policy.
    2. The relevant individual is permitted to take their staff training file with them when they leave their post within the department.

LTHT/UoL Training Courses

    1. The R&D Department offer an online GCP Training Course for all Trust staff and staff with Honorary Trust Contracts.
    2. For further information and how to enroll, contact the R&D Department. Tel: 0113 392 2878.
     

Online GCP training

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 Statutory Instrument 2006 No. 1928 states that each individual involved in conducting a trial is qualified by education, training and experience. As such, GCP training is now mandatory for all researchers involved in undertaking clinical trials .

From 1st October 2007 R & D approval will not be given where a researcher cannot demonstrate they have undertaken formal GCP training within the last two years.

GCP Training day

R&D are pleased to offer a GCP training day which will take place at the University of Leeds on Wednesday 11th June 2008 (from 9am until 4pm ) and will be delivered by Joan Perou who is an independent GCP trainer and consultant. The training will include the key principles of GCP and the 2004 statutory instruments (with amendments in 2006) and will carry 6 CPD points (from the Royal College of Physicians). The training day will cost £50, which includes delegate pack, lunch and refreshments. To book your place please fill in the registration form and fax it to R&D on 26397 or contact Ciona McLennan for a registration form via email ciona.mclennan@leedsth.nhs.uk or on extension 22878.

Can't make the training day? R&D are also offering online GCP training. For more details contact Ciona McLennan as above.

Back to CTIMP Page

 

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