tadp-2024
tadp-2024
ANTI-DOPING PROGRAMME
2024
1. Introduction ............................................................................................... 2
1.1.8 The ITIA may further delegate any aspect(s) of Doping Control
and/or Education to another Delegated Third Party/Parties.
The ITIA will require the Delegated Third Party/Parties to
perform such aspects in compliance with this Programme, the
Code, and the International Standards. Any relevant reference
to the ITIA in this Programme encompasses any such
Delegated Third Party, where applicable and within the context
of the aforementioned delegation.
1.2 Application
1.2.1 the ITF and any of its board members, directors, officers, and
employees who are involved in any aspect of Doping Control;
1.2.2 the ITIA and any of its board members, directors, officers, and
employees who are involved in any aspect of Doping Control;
1.2.3 each of the ATP, WTA, and Grand Slam Board, and any of their
respective board members, directors, officers, and employees
who are involved in any aspect of Doping Control;
1.3.1.9 cooperate fully with the ITIA and any other Anti-
Doping Organisation conducting investigations into
possible Anti-Doping Rule Violations;
1.3.2.6 cooperate fully with the ITIA and any other Anti-
Doping Organisation conducting investigations into
possible Anti-Doping Rule Violations; and
1.3.3.4 cooperate fully with the ITIA and any other Anti-
Doping Organisation conducting investigations into
possible Anti-Doping Rule Violations.
1.4.2 Each Player Support Person and other Person who is not a
Player will continue to be bound by and required to comply with
this Programme unless and until they no longer carry out the
activity (or are no longer bound by the arrangement) that
brought them within Article 1.2 in the first place.
1.4.3 Subject to Article 1.4.4, retired Players may not compete in any
Covered Event or national-level event unless they have (i)
given the ITF, the ITIA, and their NADO at least six months'
written notice of their intent to return to competition, and (ii)
made themselves available for Testing (including, if requested,
by providing whereabouts information) for a period of six
months before returning to competition. Any competitive results
obtained in violation of this Article 1.4.3 will be Disqualified,
unless the Player can establish that they could not have
reasonably known that the event they were participating in was
a Covered Event or national-level event.
1.4.4 WADA, in consultation with the ITIA and the Player's NADO,
may exempt a Player from the six-month written notice
requirement where the strict application of that requirement
would be unfair to the Player. WADA's decision to grant or not
to grant such exemption may be appealed under Article 13.
1.5.1 This Programme comes into full force and effect on 1 January
2024 (the 'Effective Date'), replacing the Tennis Anti-Doping
Programme that was in force prior to the Effective Date.
1.6 Amendments
3. Proof of doping
3.1.1 The ITIA will have the burden of establishing that an Anti-
Doping Rule Violation has occurred. The standard of proof will
be whether the ITIA has established the commission of the
Anti-Doping Rule Violation to the comfortable satisfaction of the
hearing panel, bearing in mind the seriousness of the allegation
that is made. This standard of proof in all cases is greater than
a mere balance of probability but less than proof beyond a
reasonable doubt.
4.1.2 A copy of the Prohibited List is set out at Appendix Three to this
Programme. Unless provided otherwise in the Prohibited List
or a revision thereto, the Prohibited List and revisions thereto
will come into effect automatically under this Programme three
months after their publication by WADA on
4.1.3 All Players and other Persons are bound by the Prohibited List
and any revisions thereto from the date they come into effect,
without further formality. It is the responsibility of all Players and
other Persons to be familiar with the most up-to-date version of
the Prohibited List and all revisions thereto.
4.1.4 Without prejudice to the last sentence of Article 4.1.3, the ITF
or the ITIA will take reasonable steps to publicise any
amendments made by WADA to the Prohibited List, and to
distribute the Prohibited List to National Associations. Each
National Association must in turn take reasonable steps to
distribute the Prohibited List to its members and constituents.
(a) The ITIA will notify the Player and (via ADAMS)
their NADO.
5.1.3 The ITIA will conduct test distribution planning and Testing as
required by the ISTI.
5.2.1 Subject to the limitations for Event Testing set out in Article 5.3,
the ITIA (on behalf of the ITF) will have In-Competition and Out-
of-Competition Testing authority over all of the Players
specified in Article 1.2. For the avoidance of doubt, nothing in
5.2.3 For the avoidance of doubt, the ITIA may select Players for
Target Testing so long as such Target Testing is not used for
any purpose other than legitimate anti-doping purposes.
5.3.1.1 At Covered Events, the ITIA (on behalf of the ITF) will
have authority to conduct Testing. The selection of
the Covered Events at which Testing is to take place
will be made by the ITIA, and will remain confidential
except to those Persons with a reasonable need to
know of such selection in order to facilitate such
Testing. The actual timing of the Testing at a selected
Event, and the selection of Players to be tested at
that Event, will be at the discretion of the ITIA.
5.3.3.1 from 11:59 p.m. local time on the day before the first
match of the main draw (or of the qualifying draw, if
the Player is participating in the qualifying draw) of
the first Competition in which the Player is
participating in an Event;
5.3.3.2 through to the end of the Player’s last match (in any
Competition) in the Event and the Sample collection
process related to that match that is conducted
pursuant to notification of Testing given to the Player
no more than 60 minutes after the Player's last match
(120 minutes if the Player's last match in the Event is
the final match in the Competition in question); or
5.3.3.4 (where the Player withdraws from the Event after the
time noted at Article 5.3.3.1, whether before or after
playing in any match at the Event) until the end of any
Sample collection process conducted pursuant to
notification of Testing given to the Player no more
than 60 minutes after the Player has given notice of
such withdrawal to the official at the Event specified
in the Event rules. If so requested, the Player shall
remain at the Event Venue for that 60-minute period
to allow such notification to take place. If the Player’s
withdrawal is from a doubles Competition, their
doubles partner must also submit to Testing at the
same time if requested to do so and that Testing shall
also be In-Competition Testing.
5.4.2.1 The ITIA may from time to time designate any Player
or Players for inclusion in a pool of Players to be
known as the 'International Registered Testing
Pool'. Any Player designated for inclusion in (or
removed from) the International Registered Testing
Pool will be notified of such inclusion or removal in
accordance with ISTI Article 4.8.7.
5.5.3 The ITIA will decide which Players will be selected for ABP
The ITF and the organising committees for Covered Events, as well as
National Associations and the organising committees for national-level
events, will authorise and facilitate the Independent Observer Program
at such events where so requested by WADA.
5.7.1 In addition to conducting the Testing, the ITIA has the power to
gather anti-doping intelligence and conduct investigations in
accordance with the requirements of the Code and the ISTI into
matters that may evidence or lead to the discovery of evidence
of an Anti-Doping Rule Violation. Such investigations may be
conducted in conjunction with, and/or information obtained in
such investigations may be shared with, other Signatories
(e.g., if the information relates to Players or other Persons
under their authority) and/or other relevant authorities (e.g., if
the information suggests the possible commission of a crime or
regulatory offence or breach of other rules of conduct), and/or
(where the information may evidence a breach of Section D of
the Tennis Anti-Corruption Program) it may be used by the ITIA
in furtherance of investigating such breach in accordance with
the procedures set out in Section F of the Tennis Anti-
Corruption Program, provided that the information is relevant
to the offence or breach in question and the disclosure of any
Personal Information (as defined in the ISPPPI) complies with
ISPPPI Article 8. The ITIA may stay its own anti-doping
investigation pending the outcome of
6. Analysis of Samples
6.4.4 Subject to Articles 5.3.4 and 7.11.6, the ITIA will pay the costs
of collection and analysis of Samples under this Programme.
6.8.1 WADA may, in its sole discretion at any time, with or without
prior notice, take physical possession of any Sample and
related analytical data or information in the possession of a
laboratory or Anti-Doping Organisation. Upon request by
WADA, the laboratory or Anti-Doping Organisation in
possession of the Sample or data must immediately grant
access to and enable WADA to take physical possession of the
Sample or data. If WADA has not provided prior notice to the
laboratory or Anti-Doping Organisation before taking
possession of a Sample or data, it must provide such notice to
the laboratory and Anti-Doping Organisation within a
reasonable time after taking possession.
7.2.1 The circumstances in which the ITIA (on behalf of the ITF) will
take responsibility for conducting Results Management in
respect of Anti-Doping Rule Violations involving Players and
other Persons will be determined by reference to and in
accordance with Code Article 7, the ISRM, and this Article 7.2.
7.2.2 The ITIA (on behalf of the ITF) will conduct Results
Management and the investigation of potential Anti-Doping
Rule Violations in accordance with Code Article 7, the ISRM,
and this Article 7.2.
7.2.3 Without prejudice to the generality of Article 7.2.1, the ITIA will
have Results Management authority under this Programme:
7.3.2.1 The ITIA may (at its sole discretion) submit any
review required by the ISRM (other than those
reserved for an Expert Panel) to a Review Board.
7.3.2.3 Composition:
7.3.2.5 The ITIA will send the relevant papers and evidence
to each of the Review Board members.
7.7.5 If the Review Board concludes that all of the requirements for
recording a Whereabouts Failure are met, or if the Player does
not request an administrative review, the ITIA will notify the
Player that it is recording a Whereabouts Failure against them.
7.8.2 Where the Review Board conclude that the Player or other
Person may have committed one or more Anti-Doping Rule
Violations under Article 2, the ITIA will send the Player or other
Person a Notice in accordance with Article 7.10.
7.9.2 In considering the Demand, the Review Board will have the
discretion but not the obligation to invite such submissions from
the ITIA Senior Director, Anti-Doping and the Player or other
Person in question as it sees fit.
7.9.3 If the Review Board determines that there is no good faith basis
for the Demand, (a) the ITIA Senior Director, Anti-Doping will
not pursue the Demand with the Player or other Person; and
7.9.4 If the Review Board determines that there is a good faith basis
for the Demand, then if the Player or other Person fails to
produce the information requested in the Demand the
consequences set out at Article 5.7.3 will apply.
7.10 Notice
7.10.2 Before sending the Notice to the Player or other Person, the
ITIA will refer to ADAMS and contact WADA and other relevant
Anti-Doping Organisations to determine whether the Player or
other Person has any prior Anti-Doping Violations.
7.10.3 The ITIA will send a copy of the Notice to each Interested Party.
7.11.6 Where Article 7.11.3 and/or 7.11.4 applies, the ITIA will be
responsible for the costs of the B Sample analysis. Where
Article 7.11.5 applies, the ITIA may require the Player to pay
the costs of the B Sample analysis.
7.12.3.2 Procedure:
(b) In all other cases, the ITIA will publicly announce the
Provisional Suspension.
7.13.3 The Player or other Person has the right to respond to the
Charge Letter in any one of the following ways:
7.13.4 After sending the Charge Letter, the ITIA may Publicly Disclose
the charge in accordance with Code Article 14.3.1.
7.14.2 In the event that the Player or other Person admits the Anti-
Doping Rule Violation(s) asserted and accedes to
Consequences specified by the ITIA (or is deemed to have
done so in accordance with Article 7.13.3), the ITIA will
promptly issue a reasoned decision confirming the commission
of the Anti-Doping Rule Violation(s) and the imposition of the
specified Consequences (as applicable), will send notice of the
7.14.4 In the event that the ITIA withdraws the Charge Letter, it will
promptly issue a reasoned decision confirming the withdrawal
of the Charge Letter, will send notice of the decision to the
Player or other Person and to each Interested Party, and will
Publicly Disclose the decision in accordance with Article 8.6
(save that the decision will not be Publicly Disclosed where no
Provisional Suspension was imposed and the fact that the
Player or other Person was charged has not otherwise been
made public).
8.1.5 Any other matter that may arise from time to time under this
Programme that the ITIA considers should be determined by
the Independent Tribunal.
8.4.1 A party has the right to request a public hearing. Such request
may however be denied in the interest of morals, public order,
national security, where the interests of Minors or the protection
of the private life of the parties so require, where publicity would
prejudice the interests of justice, or where the proceedings are
exclusively related to questions of law.
8.4.5 Each of the ITIA and the Player or other Person has the right
to be present and to be heard at the hearing. Each of the ITIA
and the Player or other Person also has the right (at their own
expense) to be represented at the hearing by legal counsel of
their own choosing.
8.4.6.1 The ITF, WADA, and the NADO of the Player or other
Person may attend the hearing as observers. In any
event, the ITIA will keep them fully apprised as to the
status of pending cases and the result of all hearings.
(c) with reasons, the date that such Consequences will come
into force and effect; and
8.5.3 The ITIA will pay the costs of convening the Independent
Tribunal and of staging the hearing, subject to any costs-
shifting order that the Independent Tribunal may make further
to Article 8.5.4.
8.5.4 The Independent Tribunal has the power to make a costs order
against any party, where it is proportionate to do so. If it does
not exercise that power, each party will bear its own costs,
legal, expert, hearing, and otherwise.
8.5.5 Subject only to the rights of appeal under Article 13, the
Independent Tribunal's decision will be the full, final and
complete disposition of the case and will be binding on all
parties.
With the consent of the parties and WADA, an assertion that the Player
or other Person has committed one or more Anti-doping Rule Violations
may be heard directly by CAS, with no requirement for a prior hearing.
9. Disqualification of results
10.2.2 If Article 10.2.1 does not apply, then (subject to Article 10.2.4.1)
the period of Ineligibility will be two years.
10.3.2 For an Article 2.4 Anti-Doping Rule Violation that is the Player's
first doping offence, the period of Ineligibility imposed will be
two years, subject to reduction down to a minimum of one year,
depending on the Player's degree of Fault. The flexibility
between two years and one year of Ineligibility in this Article is
not available where a pattern of last-minute whereabouts
changes or other conduct raises a serious suspicion that the
Player was trying to avoid being available for Testing.
10.3.3 For an Article 2.7 or 2.8 Anti-Doping Rule Violation that is the
Player's or other Person's first doping offence, the period of
Ineligibility imposed will be a minimum of four years up to
lifetime Ineligibility, depending on the seriousness of the
violation, provided that:
10.3.4 For an Article 2.9 Anti-Doping Rule Violation that is the Player's
or other Person's first doping offence, the period of Ineligibility
imposed will be a minimum of two years, up to lifetime
Ineligibility, depending on the seriousness of the violation.
10.14.3 Where an Event that will or may take place after the period of
Ineligibility has an entry deadline that falls during the period of
Ineligibility, the Player may submit an application for entry in
the Event in accordance with that deadline, notwithstanding
that at the time of such application they are still Ineligible.
10.16.2 The ITIA may also make reinstatement subject to the review
and approval of a Player's medical condition by the Review
Board in order to establish the Player's fitness to be reinstated.
10.16.3 Once the period of a Player's Ineligibility has expired, and the
Player has fulfilled the foregoing conditions of reinstatement,
then provided that (subject to Article 10.16.5) all amounts
forfeited under the Programme have been paid in full, and any
award of costs made against the Player by the Independent
10.16.5 Where fairness requires, the ITIA or the hearing panel may
establish an instalment plan for repayment of any Prize Money
forfeited under this Programme and/or for payment of any costs
awarded further to Article 8.5.4. The payment schedule may
extend beyond any period of Ineligibility imposed upon the
Player.
12.1 The ITF will require its National Associations to comply with, implement,
uphold, and/or enforce this Programme (or its equivalent rules) within
the National Association's area of competence, and will take such
actions as it considers necessary to enforce such compliance.
(f) WADA.
(f) WADA.
All parties to any CAS appeal must ensure that WADA and all other
parties with a right to appeal have been given timely notice of the
appeal.
In making its decision, the CAS will not give deference to the
discretion exercised by the body whose decision is being
appealed.
The ITIA must promptly provide the appeal decision to the Player or
other Person and to any Interested Party.
14.1.3 Subject strictly to Article 14.4, (a) the ITIA will send copies of
any notices sent to a Player as part of the management of an
apparent Whereabouts Failure to the ATP or WTA (as
applicable); and (b) the ITIA will send a copy of any Notice and
Charge Letter to each Interested Party, and will thereafter keep
each of them informed in relation to the status of the case under
Article 8. WADA and the NADO of the Player or other Person
(and, as applicable, the ATP or WTA and/or Grand Slam
Board) will keep the contents of the Charge Letter, and any
further information supplied to them pursuant to this Article
14.1.3, as well as any information they obtain by attending a
14.4 Confidentiality
14.4.1 The ITIA will use its reasonable endeavours to ensure that
Persons under its control do not publicly identify Players or
other Persons whose Samples have resulted in Adverse
Analytical Findings or Atypical Findings, or Atypical Passport
Findings or Adverse Passport Findings, or are alleged to have
committed an Anti-Doping Rule Violation under this
Programme, unless and until a Provisional Suspension has
been imposed or accepted, or a charge has been Publicly
Disclosed further to Article 7.13.4, or an Independent Tribunal
has determined that an Anti-Doping Rule Violation has been
14.4.2 The ITIA will ensure that its employees (whether permanent or
otherwise), contractors, agents, consultants, and Delegated
Third Parties are subject to a fully enforceable contractual duty
of confidentiality and to fully enforceable procedures for the
investigation and disciplining of improper and/or unauthorised
disclosure of such confidential information.
14.4.3 The ITIA in its discretion may at any time disclose to other
organisations such information as the ITIA may consider
necessary or appropriate to facilitate administration or
enforcement of this Programme (including, without limitation,
National Associations selecting teams for the Davis Cup or the
Billie Jean King Cup), provided that each organisation provides
assurance satisfactory to the ITIA that the organisation will
maintain all such information in confidence. The ITIA will not
comment publicly on the specific facts of a pending case (as
opposed to general description of process and science) except
in response to public comments attributed to the Player or other
Person or their representatives.
The ITIA will publish at least annually a general statistical report of its
Doping Control activities, and provide a copy to WADA. The ITIA may
also publish reports showing the name of each Player tested, frequency
with which they have been tested, the date of each Testing, the
numbers of tests conducted on Players within certain ranking groups or
categories; and the identity of Events where Testing has been carried
out.
14.6.3 To facilitate WADA’s oversight and appeal rights for TUEs, the
ITIA will report all TUE applications, decisions, and supporting
documentation using ADAMS in accordance with the
requirements and timelines contained in the ISTUE.
15.1.2 Each of the ITF, the ITIA, National Associations, the ATP, the
WTA, and the Grand Slam Board will recognise and implement
a decision and its effects as required by Article 15.1.1 on the
date that it receives actual notice of the decision.
[Comment to Article 15.1.2: This may include notifying the decision
to Persons with a need to know, in accordance with Article 14.1.5 of
the World Anti-Doping Code.]
The ITIA (on behalf of the ITF) may implement decisions rendered by
Anti-Doping Organisations that are not listed in Article 15.1, such as a
Provisional Suspension prior to a Provisional Hearing or acceptance by
the Player or other Person. Any decisions so implemented by the ITIA
will bind the ITF, National Associations, the ATP, the WTA, and the
Grand Slam Board.
The ITIA will report to WADA on the ITF's compliance with the Code in
accordance with Code Article 24 and the International Standard for
Code Compliance by Signatories.
18. Education
The ITIA will plan, implement, evaluate, and promote Education in line
with the requirements of Code Article 18.2 and the International
Standard for Education.
19.1 The official text of the Code will be maintained by WADA and published
in English and French. In the event of any conflict between the English
and French versions, the English version will prevail.
19.2 The comments annotating various provisions of the Code will be used
to interpret the Code.
19.4 The headings used for the various Parts and Articles of the Code are
for convenience only and will not be deemed part of the substance of
19.5 Where the term 'days' is used in the Code or an International Standard,
it means calendar days unless otherwise specified.
DEFINITIONS
Decision Limit. The value of the result for a threshold substance in a Sample
above which an Adverse Analytical Finding will be reported, as defined in the
ISL.
Delegated Third Party. Any Person to which the ITF, the ITIA on behalf of the
ITF, or any other Anti-Doping Organisation delegates any aspect of Doping
Control or anti-doping Education programmes including, but not limited to,
Doping Control personnel, as well as third parties or other Anti-Doping
Organisations that conduct Sample collection or other Doping Control services
or anti-doping Educational programs on behalf of the ITF, the ITIA, or other
Anti-Doping Organisation. This definition does not include the CAS.
Doping Control. All steps and processes from test distribution planning
through to ultimate disposition of any appeal and the enforcement of
Consequences, including all steps and processes in between, including (but
not limited to) Testing, investigations, whereabouts, TUEs, Sample collection
and handling, laboratory analysis, Results Management, and investigations or
proceedings relating to violations of Article 10.14 (status during Ineligibility or
Provisional Suspension).
Event Period. The period deemed to start at the same time as the In-
Competition Period and to end at midnight on the day of the last match played
in the Event.
Event Venue. The area that is the greater of (a) the city in which the Event
takes place; and (b) the area within a twenty-mile radius of the venue of the
Event.
Fault. Fault is any breach of duty or any lack of care appropriate to a particular
situation. Factors to be taken into consideration in assessing a Player's or
other Person's degree of Fault include, for example, the Player's or other
Person's experience, whether the Player or other Person is a Protected
Person, special considerations such as impairment, the degree of risk that
should have been perceived by the Player and the level of care and
investigation exercised by the Player in relation to what should have been the
perceived level of risk. In assessing the Player's or other Person's degree of
Fault, the circumstances considered must be specific and relevant to explain
the Player's or other Person's departure from the expected standard of
behaviour. Thus, for example, the fact that a Player would lose the opportunity
to earn large sums of money during a period of Ineligibility, or the fact that the
Player only has a short time left in their career, or the timing of the sporting
calendar, would not be relevant factors to be considered in reducing the period
of Ineligibility under Article 10.6.1 or 10.6.2.
Interested Party. The ITF, the Player or other Person's NADO, WADA, the
ATP or WTA (if the Player has an ATP or WTA ranking), the Grand Slam Board
(where the Anti-Doping Rule Violation in issue is based on an Adverse
Analytical Finding from a sample collected at a Grand Slam event), and any
other Anti-Doping Organisation that has a right to appeal the decision in
question under Article 13.2.
ITF. References to the ITF shall mean ITF Limited (t/a the International Tennis
Federation) and/or ITF Licensing (UK) Limited and/or their designees.
No Fault or Negligence. The Player or other Person establishing that they did
not know or suspect, and could not reasonably have known or suspected even
with the exercise of utmost caution, that they had Used or been administered
the Prohibited Substance or Prohibited Method or otherwise violated an anti-
doping rule. Except in the case of a Protected Person or Recreational Athlete,
for any violation of Article 2.1 the Player must also establish how the
Prohibited Substance entered their system.
Player. Any player subject to the Programme as set out in Article 1.2.6.
Player Support Person. Any coach, trainer, manager, agent, team staff,
official, nutritionist, medical or paramedical personnel, parent or any other
Person working with, treating or assisting a Player who is participating in or
preparing for sports Competition.
Prohibited List. The list issued by WADA identifying the Prohibited Substances
and Prohibited Methods.
Prohibited Method. Any method so described on the Prohibited List.
Protected Person. A Player or other natural Person who at the time of the Anti-
Doping Rule Violation: (i) has not reached the age of 16; or (ii) has not reached
the age of 18 and is not included in any Registered Testing Pool and has never
competed in any International Event in an open category; or (iii) for reasons
other than age has been determined to lack legal capacity under applicable
national law.
Signatories. Those entities signing the Code and agreeing to implement the
Code and the International Standards, as provided in Code Article 23.
Tampering. Intentional conduct that subverts the Doping Control process but
that would not otherwise be included in the definition of Prohibited Methods.
Tampering includes, without limitation, offering or accepting a bribe to perform
or fail to perform an act, preventing the collection of a Sample, affecting or
making impossible the analysis of a Sample, falsifying documents submitted
to an Anti-Doping Organisation or TUE committee or hearing panel, procuring
false testimony from witnesses, committing any other fraudulent act upon the
Anti-Doping Organisation or hearing body to affect Results Management or
the imposition of Consequences, and any other similar intentional interference
or Attempted interference with any aspect of Doping Control.
Target Testing. Selection of specific Players for Testing based on criteria set
out in the ISTI.
Testing. The parts of the Doping Control process involving test distribution
planning, Sample collection, Sample handling, and Sample transport to the
laboratory.
TUE Committee. A panel appointed by the ITIA and composed of at least three
physicians with experience in the care and treatment of Players and a sound
knowledge of clinical and exercise medicine. In all cases involving a Player
with a disability, one of the physicians must have experience with the care and
treatment of Players with disabilities. The ITIA may also delegate the
appointment of the panel to the International Testing Agency (ITA) or other
suitably qualified body.
2.1 Prior to providing a blood Sample (see ISTI Annex D), the Player
must sit down in a normal seated position (not lie down), with
their feet on the floor, for at least ten minutes.
A2.1
3. Collection of urine Samples and/or blood Samples
b. The DCO must keep the Samples secured and under their
control until the Samples are passed to a third party (e.g.,
the laboratory, or a courier to take them to the laboratory).
Samples collected at an Event must not be left
A2.2
unattended, unless they are locked away in a refrigerator
or cupboard or in a secure area only accessible to
authorised personnel, for example. In the absence of a
secure area where the Samples may be left, the DCO must
keep the Samples under their control. Access to Samples
must be restricted at all times to authorised personnel.
A2.3
APPENDIX THREE
A3.1
APPENDIX FOUR
INTERNATIONAL STANDARD
FOR THERAPEUTIC USE
EXEMPTIONS (ISTUE)
A4.1
APPENDIX FIVE
INTERNATIONAL STANDARD
FOR TESTING AND
INVESTIGATIONS (ISTI)
A5.1
APPENDIX SIX
INTERNATIONAL STANDARD
FOR RESULTS
MANAGEMENT (ISRM)
A6.1