clinical trial readiness checklist - huntington society of ... · the clinical trial readiness...

Clinical Trial Readiness Checklist October 2014

This checklist was developed by the Huntington Society of Canada in partnership with Rx&D, Canada’s Research-Based

Pharmaceutical Companies. While developed to assist the broader research community, this checklist can be amended to reflect

the needs of disease-specific clinical study requirements. It will be updated as required.

The clinical trial readiness checklist is a tool which can help new and experienced

researchers prepare for upcoming clinical studies. It is designed to be a quick

reference to ensure that you have the basic requirements for conducting clinical

studies, however does not replace the sponsor protocol requirements, Health

Canada/FDA regulations or Research Ethics Board considerations.

HOW IT WORKS:

REQUIRED: The items listed under the REQUIRED category are the basic items needed

for the conduct of any clinical study. Sites should ensure that they have required staff,

space and equipment, training and resources to successfully conduct the study.

RECOMMENDED/OPTIONAL: The items listed under the RECOMMENDED/OPTIONAL

category are protocol and site specific. Not all items will be necessary for you to conduct

a clinical study, so simply check off the ones that you have and make a note to speak to

the sponsor about additional items required for the protocol.

PROCESS OVERVIEW: This section provides a glimpse into the documents, activities and

considerations required in the process of conducting a clinical study.

FUTURE WORK:

This toolkit should be reviewed and updated annually, or at least, as guidance documents,

federal regulations and ethical considerations are updated. This is meant to be a dynamic

document which can be tailored for different clinical trials related to different therapeutic

areas.





Staffing Resources

Required Recommended/Optional Principal Investigator, MD (Medical Degree is

protocol dependent)

Optimal to have experience in clinical trials, as s/he ultimately must take personal responsibility for all aspects of study and the delegation of tasks. Optimal to be on-site whenever study subjects are being assessed.

Co-Investigator or Back up Investigator

This individual must understand the protocol, and should be available to fill in for the PI when s/he is away on leave, vacation or becomes ill and cannot continue the PI role.

Study Coordinator

This is usually a clinically trained individual with specific training in the conduct of clinical trials. It is most often a nurse. This person is often involved in all aspects of the study including ethics submission, all pre-study set up (lab draws, ECG, pharmacy , etc.) as well as actual study related activities which may include blood draw, ECGs and some of the rating scales (including cognitive testing), therefore experience is required.

An understanding and appreciation of the unique challenges in dealing with HD is important.

Research Manager

This applies to sites that are likely to have many active studies. This individual will provide project management and oversee the conduct of the research program. Experience in clinical trial design and conduct are an asset. Manager will oversee start-up of projects, negotiation of contracts, ethics committee submissions, protocol compliance, interaction with the monitor, and other activities throughout the course of the study and closeout.

Independent Rater

Some studies require an independent rater blinded for study procedures. This person can be a physician, however this varies according with the protocol and what is being rated.

Research Assistants/Associate

Research assistants/associates assist with the setup of a research visits, may help with lab samples with spinning blood and shipping to labs, as well as data entry. Research assistants/associates may be trained in post-graduate specialized programs focusing on clinical trials but are usually not nurses or other allied health professionals.

Phlebotomist /ECG Technician

Ability to draw, prepare and ship blood and other biological specimen samples





Space and Equipment

Required The equipment needed is protocol specific

and may be on-site or within close proximity

Physical facility to conduct studies including

sufficient space to assess patients, as per protocol

Freezer (-20°C)

Freezer (-70°C)

Fridge (2-8°C) Centrifuge Annual calibration of specific equipment

ECG

Ultrasound or MRI

X-ray if required

Internet (wireless) access IVRS experience EDC experience Experience with electronic patient diaries

Room for coordinator/monitor to work

Secure controlled area with limited access and locked for investigational new drug (IND) or investigational product (IP), with appropriate air temperature and humidity conditions that require daily monitoring and documentation.

Internet access with appropriate security measures.

Ability to provide access to EMR or clinical records for visits and sponsor monitors

Ability to store study related material for the required 25-year period (either on site or via third party)





Training

Required Recommended

Good Clinical Practice (GCP) IATA Certification – Provides certification and

ability to ship dangerous goods with courier

company access to site.

Tri-Council Policy Statement (TCPS) Tutorial

Standard Operating Procedures (SOPs) for the conduct of clinical trials (These could be purchased and customized, or generated by the site. They should be review and updated annually and available for monitor review).

Links:

GCP: Training can be provided by the sponsor at no charge. Reading material at:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

TCPS: http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

IATA: http://www.mayomedicallaboratories.com/education/online/dangerousgoods/

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php

http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/

http://www.mayomedicallaboratories.com/education/online/dangerousgoods/





Additional Considerations

Required Recommended Optional

Sufficient number of patients to reasonably be able to recruit into trials

Diverse patient population Participation in database

studies such that you can

identify candidates for clinical

trial recruitment.

i.e. ENROLL HD

Ability to reimburse patients for

travelling expenses (as per study

budget) and to manage financial

reporting of expenses.

Database of patients and clinical characteristics.




the needs of disease-specific clinical study requirements. It will be updated as required. Page 1

Expectations for the Conduct of a Clinical Trial – Process Overview Before the Clinical Trial Commences: Rule #1 – If it is not documented, it did not happen. Document and file everything. Site feasibility questionnaires and possible pre-selection visit

Investigator Meeting attendance

Preparation and submission of regulatory and ethics documents

Create REGULATORY BINDER where copies or originals of all documents are collected

Negotiation of Clinical Trial Agreement (CTA) and study budget

Curriculum vitae and/or other relevant documents evidencing qualifications of investigator(s) and sub-investigator(s)

Information given to potential study participants, ONLY UPON REB APPROVAL: Most up to date, REB Approved, Informed Consent Form (including all applicable translations) REB Approved Advertisement for subject recruitment (if applicable)

Insurance statement (where required)

Signed agreement between involved parties, e.g.:

Investigator/institution and sponsor

Investigator/institution and CRO

Sponsor and CRO Investigator/institution and authority(ies) (where required)

Dated, documented approval/favourable opinion of REB of the following:

Protocol and any amendments

CRF (if applicable)

Informed consent form(s)

Any other written information to be provided to the subjects

Advertisement for subject recruitment (if used)

Subject compensation (if any)

Any other documentation given approval/favourable opinion

REB committee composition

and REB attestation (form or clause) in Canada

Regulatory authority(ies) authorization/approval/notification of protocol (where required)

Up to date version of the study Protocol. Keep all versions in regulatory binder. All staff must be trained on the protocol.

Up to date version of the Investigator Brochure. Keep all versions in regulatory binder.

Normal value(s)/ranges for medical/laboratory/technical procedures and/or tests included in the protocol

Medical/ laboratory/technical procedures/tests (where required)

Certification or

Accreditation or

Established quality control and/or external quality assessment or Other validation (where required)

Instructions for handling of investigational product(s) and trial-related materials (if not included in IB)

Decoding procedures for blinded trials

All sponsor communication and reports

Clinical Trial Readiness Checklist




During the Clinical Conduct of the Trial Management of patient selection, screening and study visit conduct. (create a participant master list,

enrolment and screening list)

Any revisions the following documents should be reviewed and filed in the regulatory binder:

Investigator Brochure

Protocol/amendment(s) and CRF

Informed consent form

Any other written information provided to subjects

Advertisement for subject recruitment (if used)

Dated, documented approval/favourable opinion of the REB of the following:

Protocol amendment(s)

Revision(s) of: o Informed consent form o Any other written information to be provided to the subjects o Advertisement for subject recruitment (if used)

Any other documentation given approval/favourable opinion

Continuing review of trial (where required)

Regulatory authority(ies) authorization/approval/notification where required for:

Protocol amendment(s) and other documents

Updated Curriculum vitae and medical license for new investigator(s) and/or sub-investigator(s)

Updates to normal value(s)/ranges for medical/laboratory/technical procedures and/or tests included in the protocol

Updates of medical/ laboratory/technical procedures/tests

Certification or

Accreditation or

Established quality control and/or external quality assessment or

Other validation (where required)

Documentation of investigational product(s) and trial-related materials shipment

Relevant communications, including monitoring visits

Letters /newsletters, Meeting notes, Notes of telephone calls

Signed informed consent forms. Kept in participant binder/folder or regulatory binder

Source documents. Kept in participant binder/folder. Site will develop and utilize source documents specific for each study

Copies of signed, dated and completed CRFs

Copies of documentation of CRF corrections

Notification of originating investigator to sponsor of serious adverse events and related reports

Notification by sponsor and/or investigator, where applicable, to regulatory authority(ies) and REBs of unexpected serious adverse drug reactions and of other safety information

Notification by sponsor to investigators of safety information

Interim or annual reports to REB authority(ies)

Updated participant screening log

Updated participant identification code list

Updated participant enrolment log

Investigational products accountability at the site

Signature sheet (of all persons authorized to make entries and/or corrections on CRFs)

Clinical Trial Readiness Checklist




Record of retained body fluids/tissue samples (if any)

After Completion or Termination of the Trial Reconcile Investigational product(s) accountability at the site

Documentation of Investigational product destruction

Completed subject identification code list

Final report by investigator to REB where required, and where applicable, to the regulatory authority(ies)

Clinical study report (if applicable)

Measurement of Success a. Reasonable time to start up of study including ethics approvals and contract negotiation. b. Protocol deviations should be held to a minimum. c. Few screening failures, recruited subjects meeting all inclusion/exclusion criteria. d. Reporting to Ethics Committee and sponsor within timelines identified. e. Meeting targets for recruitment. f. Quality data including data entry and source record validation. g. Excellent retention of subjects within study. h. Site protection of subject confidentiality.

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