TRAINING

CONCLUSIONS

Background: As sponsor for international oncology clinical trials, the Canadian Cancer Trials Group (CCTG) has an obligation to follow Good Clinical Practice (GCP) requirements. GCP states that the sponsor is responsible for selecting the investigator(s)/institution(s) and ensuring each investigator is qualified by training and experience.

CCTG mandates generic training such as GCP, ethics and more recently Canadian Food and Drug Act Part C Division 5 training. The site training program has been enhanced to include web-based protocol-specific training, including information regarding the conduct of the study, investigational medicinal product, trial procedures and duties.

Methods: The CCTG Site Training SOP outlines its policy for general training and protocol-specific training requirements. A template set of protocol-specific training slides was developed to ensure consistency in training material presented across all studies. A web-based Site Training Utility (STU) was created and launched to house both protocol-specific training slides and other training materials. STU has an attestation feature and training can be tracked for all participants. The utility provides certificates of training. Training on a CCTG protocol must be completed by the Qualified Investigator prior to activation of the study. The qualified Investigator is also responsible for training of staff with delegated duties at their own institution and can utilize the web-based materials for this purpose. If additional training for protocol amendments is required, the system can accommodate this.

Conclusion: The Site Training Utility provides a cost-effective means of delivering required clinical trials training and has shown to be highly acceptable to our participating sites. This eliminates the cost of study start-up meetings or face-to-face training. Templated slides ensure a level of consistency regarding the content of training and allows CCTG to meet its regulatory requirements for training. Issues that are currently being addressed include introducing reminders for overdue training among other improvements.

CANADIAN CANCER TRIALS GROUP • Cooperative oncology group which carries out clinical trials in cancer therapy,

supportive care and prevention across Canada and internationally

• Conducts 40-60 studies at any one time and act as regulatory sponsor in Canada

• A national program of the Canadian Cancer Society (CCS)

SPONSOR REQUIREMENTS FOR TRAINING • Good Clinical Practice (GCP) requires sponsor to select participating sites and

also ensure each investigator is qualified by training and experience

• As sponsor, the Canadian Cancer Trials Group (CCTG) mandates generic training (GCP, National Institutes of Health ethics, Canadian Food and Drug Act Part C Division 5) as well as protocol training regarding trial procedures and duties

• Development of Site Training SOP laid the groundwork for Site Training Utility to house all training needs

GCP AND TRAINING

GCP

Principles 2.8: Each individual involved in conducting a trial should be qualified by education, training and experience to perform his or her respective task(s)

Investigator Responsibilities

4.1.1: The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial

4.1.3: The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements

Sponsor Responsibilities

5.6.1: The sponsor is responsible for selecting the investigator(s)/institution(s). Each investigator should be qualified by training and experience

5.18.2 b: Selection and Qualifications of Monitors – monitors should be appropriately trained

5.18.4 g: Monitor's Responsibilities - ensure that the investigator/ trial staff are adequately informed about the trial

5.19.2 b: Selection and Qualification of Auditors - the auditors should be qualified by training and experience

WHAT TRAINING IS REQUIRED TO PARTICIPATE ON CCTG STUDIES?

1. National Institutes of Health (NIH) - Protecting Human Research Participants

2. International Conference on Harmonization - Good Clinical Practices (ICH-GCP)

3. Canadian Food and Drug Regulations, Part C, Division 5

4. Protocol Training

5. CCTG Supplementary Training, as required

6. Medidata Rave Training, as required

ALL TRAINING REQUIREMENTS AVAILABLE ON CCTG WEBSITE

CANADIAN CANCER TRIALS GROUP WEBSITE TRAINING TOOLBOX

NATIONAL INSTITUTES OF HEALTH TRAINING

GCP / DIVISION 5 TRAINING MENU

GCP / DIVISION 5 PERSONAL TRAINING SUMMARY

CCTG SITE TRAINING UTILITY (STU)

PERSONAL TRAINING MENU – PROTOCOLS

• Study trial team develops protocol training slides from template slides and protocol

• Use of template slides ensures consistency in training materials across all studies

• Information including conduct of study, investigational medicinal product, trial procedures and duties

• Both Canadian Cancer Trials Group internal staff and external study participants (Qualified Investigators) must complete training on the protocol

• Training on Canadian Cancer Trials Group protocols must be completed by the Qualified Investigator prior to study participation

• Qualified Investigator is responsible for training staff at their own institution with delegated duties on the study

• Staff may access Site Training Utility or conduct local site training meetings where attendance is documented

• The Site Training Utility enables tracking of all training

• Canadian Cancer Trials Group Site Training Utility is a cost-effective means to deliver required training

• Eliminates cost of study start-up meetings and has been highly accepted by participating centres

• Availability of templated slides ensure a level of consistency in content of training

• Certificates are available to save or print

• Future initiatives include introduction of training reminders for overdue training

Topics Covered In Protocol Template

Slides Background information and

rationale Trial objectives Treatment schema Study design Eligibility/ineligibility criteria,

statement re: exceptions Registration/randomization Pre-treatment investigations Treatment plan (include pre-

meds, concomitant meds) Adverse events management

(dose modifications) Evaluations during treatment Discontinuation of protocol

therapy Evaluations after treatment

discontinuation Endpoint measurement (may

include separate RECIST slide set)

Therapy after treatment d/c Patient reported outcomes Statistical design SAE reporting Correlative studies CRF, supporting doc

requirements including timelines

Drug supply Treatment unblinding IG: Canadian logistics Trial specific audit and

monitoring TMF / ISF (non protocol

requirement Trial contact names

The Canadian Cancer Trials Group is supported by the Canadian Cancer Society Research Institute.

ABSTRACT TRAINING PROTOCOL TRAINING

LAUNCHING THE CANADIAN CANCER TRIALS GROUP SITE TRAINING INITIATIVE

Marina S. Djurfeldt, Teddy Brown, Carolyn F. Wilson, Catherine Elliott, Bryn Fisher, Anna Sadura

Canadian Cancer Trials Group, Kingston, Ontario, Canada