Approved studies

Prepare local study paperwork

Trial documentation such as participant information sheets, consent forms, GP letter templates, case report forms and other trial related paperwork must include local contact details and be on local headed paper. All documentation should be ready to be included in the site specific assessment application.

Case report forms for multi-site studies must be in a standard format to capture the required data at all sites. Supplemental case report forms should be provided to capture any additional data.

Companies that sponsor commercial studies often provide a site study file. Academic studies are responsible for creating site files from scratch using templates from the National Institute of Health Research (NIHR) or the R&D team. Templates are generic and not all sections may apply to every study, but they can be adapted as required.

• R&D templates

Delegate duties

Before the study starts, the Research team must be assigned responsibilities that authorises staff to perform tasks in line with their training and qualifications.

Delegation of roles and responsibilities must be:

• documented
• signed by the individual taking on the task(s)
• authorised by the principal investigator

Chief investigators are responsible for coordinating and documenting all participating investigators prior to the start of the study. This can be completed by ensuring local investigator CVs and good clinical practice evidence is provided to the Research team in the delegation of duties log.

Download an example "delegation of duties log" from the templates page.

• R&D templates

Confirm staff training

Staff involved in research studies must be appropriately qualified or undergo training. Any additional staff training should be arranged before the study starts. Training records should be maintained and updated throughout the study.

CVs and good clinical practice certificates of the staff involved in the study should be collected for the site file before the study starts.  

The chief investigator must ensure that all investigators and trial staff are trained on current protocol and study specific procedures. All investigators must be provided instructions on:

• following protocol 
• complying with uniform standards for assessments of clinical and laboratory findings
• completing case report forms

Confirm investigational product management

Trials pharmacist

An individual must be identified and included in the delegation of duties log to take account of investigational products at the study site. This tends to be a nominated trials pharmacist.

The trials pharmacist should check the following to ensure good clinical practice compliance:

• Storage conditions outlined in the investigator brochure and/or the product characteristics summary can be met
• Adequate facilities are available for reconstitution of fluids and conduct of procedures where required
• Product infusion devices are available when needed

Principle investigator

The principle investigator is expected to ensure that:

• the responsibility for investigational product accountability at the study sites is taken
• all or some of their investigational product accountability duties are assigned to an appropriate pharmacist or an individual under supervision of the principle investigator
• records of the following are kept in the pharmacy file which and should be archived along with the main site file:
  
  • Product delivery to study sites
  • Site inventory
  • Amount used by each staff member
  • Returning unused products to the sponsor or alternative disposal
• robust mechanisms are in place to ensure that study products are not made available to the subject before all the necessary approvals and documentation are in place (including a qualified person certification where applicable)
• records are maintained and document that study subjects were provided the dose specified in the study protocol and all investigational products received from the sponsor are reconciled
• investigational products are stored as specified by the sponsor and in accordance with applicable regulatory requirements
• investigational products are only used in accordance with the approved study protocol and safety reference information (as documented within the investigator brochure or summary of product characteristics where applicable)
• the appropriate person explains the correct use of the investigational products to each study subject and checks, at appropriate intervals, that they are following instructions properly and, where appropriate, compliance with study protocol requirements is documented

Identifying, recruiting and enrolling subjects

On behalf of the prematurely un-blinded, the research nurse is expected to ensure:

• that patients who are identified on paper as being possibly suitable are checked against the inclusion/exclusion criteria prior to being approached. This speeds up making contact in clinic and rules out those who are not suitable so the principle investigator can maximise who they talk to about the study
• a suitable number of subjects who meet the study protocol criteria are recruited within an agreed period
• records of screening, subject identification, enrolment and, where applicable, randomisation are held in the study file in the confidence of the investigator, unless consent is explicitly given by the trial subject that any of the information can be shared

Randomisation

The randomisation process should be performed in accordance with the study protocol. Randomisation procedures should be clearly documented and it should be outlined if paper or web-based applications will be used.

Authorised research staff who are responsible for randomisation must be identified in the delegation of duties log. In some instances, sponsors have an agreement with a trials unit to perform randomisation with their own procedures to be adhered to.

Maintaining the blind and unblinding considerations

The following considerations must be taken into account for studies that involve blinding:

• Identify an authorised team member to ensure the blind is maintained and has access to the codes (ideally this person should be independent to data collection and validation)
• Randomisation code access for double-blind studies is restricted and withheld from operational research staff except when access is required in an emergency
• The code is only broken in accordance with study protocol
• Principle investigators must document prematurely unblinded studies, provide an explanation to the sponsor (e.g. accidental or due to serious adverse event) and consider any appropriate onward reporting procedures (e.g. urgent safety measures and/or serious adverse event/suspected unexpected serious adverse reaction reports)

Obtaining informed consent

Informed consent is the process of obtaining permission from a potential participant before carrying out any intervention or study specific procedures on them.

Potential participants must be provided with all of the information relating to the study which includes the:

• nature of the procedures involved
• benefits
• risks
• potential implications of the research project

They should be allowed time to fully consider their involvement based on the information provided in accordance with the study protocol.

All staff authorised to take consent have a duty towards protecting the rights, safety and wellbeing of a potential trial participant and must adhere to the instructions provided in the study protocol and any study specific procedures.

The principle investigator is expected to ensure compliance with appropriate regulatory requirements, adhere to good clinical practice and that ethical principles have their origin in the Declaration of Helsinki when obtaining and documenting informed consent.

Medical care of study subjects

The medical care of study subjects will be provided by a qualified physician who is an investigator or sub-investigator. However, the responsibility of medical intervention is with University Hospitals Birmingham NHS Foundation Trust (UHB).

The study should ensure that:

• the participants' rights, safety and wellbeing take precedent and are protected in all circumstances
• adequate medical care is provided to a subject for any adverse events or related follow up events in accordance with the requirements and time scales specified in legislation and appropriate guidance
• the investigator informs the subject’s GP about their study participation, provided the subject agrees to the GP being informed
• the principle investigator makes a reasonable effort to ascertain the reasons for a subject withdrawing prematurely from a study