Download regulatory rapporteur style guide

REGULATORY RAPPORTEUR STYLE GUIDE
Note: The European Commission has a very useful online publication that comprehensively
covers uniformity relating to stylistic rules and conventions which must be used by all
institutions, bodies and agencies of the EU for document production. It can be found online
at: publications.europa.eu/code/en/en-000100.htm
AAA
abbreviations/acronyms
• No full stops in abbreviations, or between initials: EU, US, ICH, NICE, eg, ie,
Regulation No 10101, Michael S Brown, B Braun Medical, etc.
• To avoid awkward breaks across two lines, eg, between Phase I; Regulation No; Article 1;
Dr Smith; use non-break space [CTRL + SHIFT + Spacebar on PCs; APPLE + Spacebar
on Macs]
• Do not spell out: EU, FDA, ICH, US, UK. Prefer to explain but not spell out other common
regulatory abbreviations, along the lines of, eg: ‘the UK regulator, the MHRA’; ‘China’s
regulatory agency, the CFDA’; ‘the US industry trade association, PhRMA’
• Spell out other abbreviations on first mention, eg: marketing authorisation (MA); European
Medicines Agency (EMA); decentralised procedure (DCP); standard operating procedures
(SOPs).
• Note: The FDA (not FDA); The WHO (not WHO)
accents
Use accents on French, German, Spanish and Irish Gaelic words (but not anglicised French
words such as cafe, unless the word may be misread, eg, use exposé, résumé)
Act/act
Cap up initial when using full name, eg, Food and Drug Administration Amendments Act
(FDAAA); but l/c on second reference, eg, ‘the act’, and when speaking in more general
terms, eg, ‘we need a revised freedom of information act’; bills remain l/c until passed into
law
administration (US)
l/c for the Bush administration, the Obama administration, etc
advanced therapies
l/c, but Advanced Therapy Regulation
Note: Full title of these products – “advanced therapy medicinal products (ATMPs)”
adverbs
No hyphens after adverbs ending in -ly, eg a hotly disputed decision, a constantly evolving
journal, genetically modified food, etc; but hyphens are needed with short and common
adverbs, eg, ill-prepared submission; well-known Regulation; hard-won legislation
adviser
not advisor
affect/effect
Example: rules in the style guide had no effect (noun) on the number of mistakes; the number
of mistakes was not affected (verb) by rules in the style guide; we hope to effect (verb) a
change in this
ageing, not aging
write: aged 40–60 years [not ‘age’ and not ‘to’; use en-dash (long hyphen), not standard
hyphen] (See also: “hyphens”]
agency
l/c, including, for example, ‘the Greek agency, EOF’, unless talking about a specific agency
with the word ‘agency’ in its title
aggravate
to make worse, not to annoy
ahead of
avoid: use before or in advance of
all right
is right; ‘alright’ is not all right
ambassador
l/c, eg, the British ambassador to Washington
American universities
Take care: ‘University of X’ is not the same as ‘X University’ – most US states have two
large public universities, eg, University of Kentucky and Kentucky State University,
University of Illinois/Illinois State University, etc.
NB: Check spellings, eg, Johns Hopkins University, not John Hopkins; Stanford University,
not Stamford.
amid
not amidst
among
not amongst
among or between?
‘between’ is not limited to two parties. It is appropriate when the relationship is essentially
reciprocal, eg: differences between the members of ICH; harmonisation between the ICH
countries. ‘Among’ is used for distributive relationships: shared among the EU member
states, etc
ampersand [&]
use in company names/conference titles/publication names only when the originator does,
eg: Merck & Co; Johnson & Johnson; Annual Conference on Regulatory Affairs &
Pharmacovigilance. Otherwise, spell out
anticipate
take action in expectation of; not synonymous with expect
anticancers
no hyphen
antidepressants
no hyphen
apostrophes
Use apostrophes in: five years’ experience; two days’ time; 12 years’ exclusivity; where the
time period (two days) modifies a noun (time), but not in nine months pregnant or three
weeks old, where the time period is adverbial (modifying an adjective such as pregnant or
old) – if in doubt, test with a singular such as one day’s time, one month pregnant
Apostrophes matter for clarity – consider these four phrases, each of which means something
different:
my colleague’s patient’s medications [ie, a patient of my colleague]
my colleague’s patients’ medications [ie, patients of my colleague]
my colleagues’ patient’s medications [ie, a patient of my colleagues]
my colleagues’ patients’ medications [ie, patients of my colleagues]
appendix
plural, appendices
approach
avoid where possible, eg, ‘a proactive approach to pharmacovigilance’ becomes ‘proactive
pharmacovigilance’
around (meaning: approximately)
use instead of ‘about’: eg, ‘around US$900 million’ or ‘around 2,000 patients’
author listings in author boxes/references
author boxes – list all authors
author box listing details – Author full name (no title); job title; organisation, county/state;
country. (No web address.)
authors in references – name only three before ‘et al’ as a general rule; et al in italics
author names
No titles, or degree status, eg, delete ‘Dr’, ‘Professor’, ‘PhD’, ‘MSc’, both on Contents Page
and in Author boxes. Simply use: John Brown, Mary Smith. [But always use titles in text
when referring to people who are not the authors, eg, speakers in Meeting Reports]
average, mean and median
Although we loosely refer to the ‘average’ in many contexts (eg, cost of developing a drug),
there are two useful averages worth distinguishing.
What is commonly known as the average is the mean: everyone’s wages are added up and
divided by the number of wage earners. The median is described as ‘the value below which
50% of employees fall’, ie, it is the wage earned by the middle person when everyone’s wages
are lined up from smallest to largest. (For even numbers there are two middle people, but you
calculate the mean average of their two wages.)
The median is often a more useful guide than the mean, which can be distorted by figures at
one extreme or the other.
awards, prizes, medals
generally l/c, eg: Nobel peace prize, Fields medal (exception: TOPRA’s Awards for
Regulatory Excellence); note that awards categories are l/c, eg, ‘Company X won the best
drug delivery programme’
BBB
bacteria
plural of bacterium, so ‘the bacteria are’
before rather than ‘prior to...’
benefited, benefiting
Betaferon
TM; the generic term for the drug is lower-case initial letter, interferon-beta 1b
big, large
both preferable to massive, giant, mammoth
bill/Bill
l/c, even when giving full name; cap up only if it becomes an act
billion
one thousand million, not one million million
spell out in full, six billion people, US$10 billion, etc
Bombay
now Mumbai
newspaper and journal titles
Italicised, both in body text and in references: The Lancet, New England Medical Journal,
The Washington Post
bottleneck
no hyphen
brackets in speech
‘Square brackets,’ the grammarian said, ‘are used in direct quotes when an interpolation [a
note from the writer, not uttered by the speaker] is added to provide essential information.’
bullet points
(also known as blobs) should normally appear in Regulatory Rapporteur like this:
• Initial cap at start and no full stop until end of final bullet
• Bullets full out, then indented to text.
but, however
often redundant, and increasingly wrongly used to connect two compatible statements; ‘in
contrast, however, ...’ is tautologous
CCC
capitals
here are the main principles:
• job designations/titles: all l/c
eg, prime minister, US secretary of state, editor of Regulatory Rapporteur
• British government departments of state, when using the proper name: All initial caps
eg, Home Office, Foreign Office, Ministry of Defence (MoD on second mention). But when
not the proper name, use l/c, eg, state department, health ministry
• universities and colleges of further and higher education:
caps for institution, l/c for departments [in body copy]
eg, Cambridge University department of medicine, Oregon State University, Free University
of Berlin, University of Queensland school of medicine
• Common RA industry terms
Always l/c, followed by abbreviation at first mention, eg, investigational medicinal product
(IMP), investigational medicinal product dossier (IMPD)
centralised procedure (CP)
lower case initial letters
chair or chairperson
not chairman or chairwoman
clearcut (one word)
clinical trials – Phase I, II, III not Phase 1, 2, 3
clinical trial application (l/c)
sometimes abbreviated to CTA but care is needed as CTA can also refer to clinical trial
authorisation or clinical trial assay – check with author if unclear
Clinical Trials Directive (cap up)
collective nouns
nouns such as committee, company, team, regulatory agency, take a singular verb or pronoun
when thought of as a single unit, but a plural verb or pronoun when thought of as a collection
of individuals:
the agency gave its unanimous approval to the plans;
the agency had a coffee break after their working lunch
the agency gave its thoughts on the new legislation;
the agency were sitting in the conference room, sharing their thoughts
but staff are always plural
colon (punctuation)
initial cap follows a colon in headlines, but l/c in the main body text
commas
‘The associate editor, John Brown, is an aficionado of house style guides’ – correct (commas)
if there is only one; ‘The associate editor John Brown is an aficionado of house style guides’ –
correct (no commas) if there is more than one associate editor.
common technical document (CTD) (not “dossier”)
but authors may use this abbreviation to mean Clinical Trials Directive – check with author if
unclear
He/she commented
avoid: prefer ‘he/she said’
companies
 always in the singular, eg, GlaxoSmithKline is launching a new product
 always spell out in full, eg, GlaxoSmithKline not Glaxo, or GSK.
competent authority(ies)
l/c unless talking about a specific CA, eg, the UK Competent Authority
Commission, as in European Commission
cap up initial C when using “the Commission noted…” (Always write “European
Commission” at first mention)
compare(d) to/with
(see explanation below, but will almost always be ‘compared with’ in Regulatory Rapporteur
copy)
• the former means liken to, the latter means make a comparison; so unless you are
specifically likening someone or something to someone or something else, use compare with:
the CEO compared himself to Albert Einstein because he believed he was like Einstein; I
might compare him with Einstein to assess their relative merits
comprise
to consist of; ‘comprise of’ is wrong
conflicts of interest
(not conflicts of interests, or conflict of interests)
Congress (US)
Cap C
convince/persuade
having convinced someone of the facts, you might persuade them to do something
cooperate, cooperation, cooperative
no hyphen
coordinate
no hyphen
countries/regions
• UK (not Great Britain, Britain, GB)
• US (not USA, America)
• the Netherlands (not The Netherlands)
• Holland: do not use when you mean the Netherlands (of which it is a region)
• Colombia vs Columbia: South American country of Colombia vs District of Columbia
(Washington DC) and Columbia University (New York)
• Europe includes the UK, so don’t say, for example, something is common ‘in Europe’ unless
it is common in the UK as well; to distinguish between the UK and the rest of Europe, the
phrase ‘continental Europe’ can be used (eg, regulations between the UK and continental
Europe can differ); other differentiators include central Europe, eastern Europe, western
Europe, etc.
• Ukraine (not ‘the Ukraine’); adjective Ukrainian
• Oceania, a preferable term to Australasia, (see Oceania for further definition)
currencies
• Abbreviate dollars like this: US$50 (US dollars); A$50 (Australian dollars); HK$50
(Hong Kong dollars; no space between currency signs and figures)
• Convert all UK sterling amounts to US$ in brackets at first mention, eg, £50,000
(US$73,700)
• Use symbols, not words, when depicting sums of money, for: £, $, €, ¥ [Note: ¥ is the
currency symbol used for the Japanese yen (JPY) and the Chinese yuan (CNY)]
• When the whole word is used, it is l/c: euro, pound, sterling, yen, dong, etc.
DDD
data
takes a plural verb: the data were checked
dates
• days of the week are not normally used in dates
• the day number always comes before the month: 1 January 2009
• 1980s, 1990s (no apostrophe, and no short form, ie, 90’s)
• 21st century; fourth century BC; AD2006 but 1000BC
decentralised procedure (DCP)
lower case initial letters
defuse
render harmless; diffuse = spread around
developing countries
use this term in preference to ‘third world’
different from
not different to or than
direct speech
People we interview are allowed to speak in their own, not necessarily Regulatory
Rapporteur’s, style, but be sensitive: do not, for example, expose someone to ridicule for
dialect or grammatical errors.
disk (computers)
not disc
drug companies, drugmakers
drug names
• Brand name capped up followed by generic name in brackets, eg: Avastin (bevacizumab).
• Do not use registered trademark® or ™ symbols following the brand names
• Typically use European brand name vs US (eg, Glivec vs Gleevec), unless it is most
commonly known by its US name.
due to/owing to
For example, compare: ‘It was difficult to assess the changes due to outside factors,’ with: ‘It
was difficult to assess the changes owing to outside factors’. The first says the changes that
were a result of outside factors were difficult to assess, the second says outside factors made
the changes difficult to assess (if in doubt, because of can be substituted for owing to, but not
due to)
EEE
earpiece/running head
Cap up first initial only
E coli
as with other taxonomic names, italicise in copy but roman in headlines and standfirsts; no
full stop [use non-break space to keep together]
eCTD (no hyphen)
efficacy vs effectiveness*
•
•
•
•
Efficacy: The extent to which an intervention does more good than harm under ideal
circumstances.
Relative efficacy: The extent to which an intervention does more good than harm, under ideal
circumstances, compared with one or more alternative interventions.
Effectiveness: The extent to which an intervention does more good than harm when provided
under the usual circumstances of healthcare practice.
Relative effectiveness (aka comparative effectiveness, US): The extent to which an intervention
does more good than harm compared with one or more intervention alternatives for achieving the
desired results when provided under the usual circumstances of healthcare practice.
*Definitions developed by the EU High Level Pharmaceutical Forum, ‘Core principles on relative effectiveness, Final report
2005–2008’. http://ec.europa.eu/pharmaforum/docs/ev_20081002_frep_en.pdf (accessed March 2011).
ellipses [...]
use spaces before and after ellipses, and three dots (with no spaces between them), when parts
of a direct speech are cut, eg: ‘She told me she didn’t want to enrol on the trial ... her main
concern was leaving her children’
email (no hyphen)
endpoints (no hyphen)
enrol, enrolling, enrolment
EU
European Union (no need to spell out at first mention); formerly EC (European Community);
before that EEC (European Economic Community)
EU presidents
There are three, so don’t say ‘EU president’ or ‘president of the union’ without making clear
which you mean: president of the European Commission, president of the European
Parliament, or holder of the rotating presidency (technically ‘president in office of the council
of the European Union’), which rotates among the EU member states every six months
EudraCT
database of all clinical trials commencing in the EC from 1 May 2004 onwards
EudraLex
the sets of rules and regulations governing medicinal products in the EU
EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance)
the European data processing network and management system for reporting and evaluation
of suspected adverse reactions during drug development and following the marketing
authorisation of medicinal products in the European Economic Area (EEA).
euro (l/c)
currency; plural euros and cents
FFF
FDA
‘US FDA’ not just FDA at first mention. Add ‘the’ in front, (Americans use ‘FDA says’,
rather than ‘the FDA says’)
fewer or less?
fewer means smaller in number, eg fewer drugs; less means smaller in quantity, eg less drugs
first, second, third
rather than firstly, secondly, thirdly
figures/tables/graphs/diagrams
• Must be referred to in the text at appropriate point, eg, (see Figure 1) – and in the right
order.
• when referring to a sidebar or box of text, write “(see Box)”.
• colon after figure number, eg, Figure 1: Xxxxxxxxxxxxx; title in lower case (after first
initial) except where it contains words that are capitalised anyway; no full stop
• check for coherence in a table (for example, that numbers in columns add up to the total
shown) and for consistency with references to the Figures in the text
• ensure each axis is labelled to indicate what the figures represent (eg: ‘number of trials’,
‘number of patients’)
focused, focusing
foetus
not fetus
fulfil, fulfilling, fulfilment
GGG
G8
Canada, France, Germany, Italy, Japan, the UK, the US and Russia
Geographical areas, caps vs l/c
• l/c for regions: the north, the south of England, the south-west, north-east England; the same
applies to geopolitical areas: the west, western Europe, far east, south-east Asia, central
America etc.
• cap up, though, when part of the name of a county (West Sussex, East Riding) or province
(East Java, North Sulawesi, etc)
• note the following: West Country, Middle East, Latin America, North America
government
l/c in all contexts and all countries
Great Britain vs the UK
England, Wales and Scotland; if including Northern Ireland, use the UK
Guideline(s)
• Cap up initial if referring to a specific Guideline; l/c if referring to guidelines in general
• within article text, guideline names should be in double quote marks; title written in l/c after
initial cap on first word, apart from words that are capitalised anyway.
HHH
headlines/crossheads/contents titles: Cap up initial of first word only
• Cap follows a colon (though this is not the case in the main body text)
headquarters
can be used as a singular (‘a large headquarters’) or plural (‘our headquarters are in London’);
HQ, however, takes the singular
Heads of Medicines Agencies (all plural)
healthcare
(one word)
homogeneous vs homogenous
homogeneous = uniform, of the same kind; homogenous (biology) = having a common
descent; the latter is often misspelt/misused for the former
Huntington’s disease (not Huntingdon’s)
formerly known as Huntington’s chorea
hyphens
There are three lengths of what can be called dashes or hyphens: hyphen (-), en-dash (–) and
em-dash (—). [Note: en-dash so called because it’s the length of an ‘n’; m-dash is the length
of an ‘m’.]
en-dash is used to represent the word “to”, eg, 12–14 January; benefit–risk ratio. Note no
spaces between the figures/words. It is also used to separate parenthetical statements – such as
this one – in which case spaces should separate the en-dash from the words around it. To
create an en-dash in Word, use CTRL + minus sign on number pad. In InDesign, it’s ALT +
hyphen.
em-dash is not house style. Convert any em-dashes to en-dashes.
When to use/not to use hyphens: Our style is to use one word wherever possible to avoid
cluttering up text (particularly as the printing process breaks already-hyphenated words at the
end of lines). This is a widespread trend in written English. Inventions, ideas and new
concepts often begin life as two words, then become hyphenated, before finally becoming
accepted as one word. ‘Wire-less’ and ‘down-stairs’ were once hyphenated. As examples,
words such as website, laptop and email, should now all be one word (and l/c) in our
publications, as should thinktank, clearcut, longlist, shortlist.
Prefixes such as macro, mega, micro, mini, multi, over, super and under rarely need hyphens.
Hyphens should, however, be used to form short compound adjectives, eg, two-tier health
service, ten-year patent, 19th-century physician, etc.
Do not use hyphens after adverbs ending in -ly, eg, politically naive, wholly owned, but when
an adverb is also an adjective (eg, hard), the hyphen is required to avoid ambiguity – it’s not a
hard, pressed scientist, but a hard-pressed one; an ill-prepared report, rather than an ill,
prepared one.
Use hyphens with short and common adverbs: much-needed treatment, well-established
principle (note though that in the construction ‘the principle is well established’ there is no
need to hyphenate). Hyphenate ‘side-effect’.
Hyphenate if followed by vowel, not if consonant eg, re-examine but rerun. Exceptions are
coordinate/coodinator; cooperate/cooperative.
Do not hyphenate crossover, antidepressant, gastrointestinal, lifecycle, dataset, multicentre,
heart rate, healthcare, website, multisite, multidisciplinary.
Do hyphenate electronic shortening only when it is unclear, eg, eLearning, eCTD, but
e-commerce
Do hyphenate post-approval, hold-up, post-marketing, sub-anything, real-world, noncompliance, long-term (in, eg, long-term commitment; but NOT in, eg, in the long term)
When referring to ranges, use en-dash (ie CTRL + minus sign on number pad), for instance,
30–40.
III
ICH-GCP
No need to spell out in full
ie,
no full stops, but comma follows, ie, like this (also eg)
immune to, not immune from
impracticable vs impractical:
impracticable = impossible, it cannot be done
impractical = possible in theory but not workable at the moment
inadmissible, not “-able”
Indian placenames
the former Bombay is now known as Mumbai, Madras is now Chennai, Calcutta is now
Kolkata and Bangalore is now Bengalooru
infer/imply
to infer is to deduce something from evidence; to imply is to hint at something (and wait for
someone to infer it)
inpatient, outpatient
no hyphens
install, instalment
instil, instilled, instilling
internet – l/c
introductory phrases
such as ‘However’, ‘Nonetheless’, ‘Instead’, should all be followed by a comma
-ise
not -ize at end of word, eg, maximise, synthesise
italics
- Use for journals/monographs/books titles. No quotation marks. Cap up initials of each word.
- All Latin words and phrases, eg, et al, ad hoc, in vitro, in vivo, in silico (use non-break space
to keep words together)
its, it’s (never its’)
If you can substitute the word with "it is" or "it has" then you want the contraction "it’s"
 It’s a new clinical trial
 It’s been more than a year
If you can replace the word with "his" or "her" and it makes sense, then you want the
possessive "its"
 The organisation is strong, but its rules are weak
 The world is its oyster
JJJ
Johns Hopkins University
not John Hopkins
judgment
KKK
Keywords:
Cap up first initial of each key word or phrase, semi-colon between each, full stop on final
keyword, eg:
Biologicals; Antibody drugs; Carcinogenicity; Cellular proliferation assays.
kilogram/s, kilojoule/s, kilometre/s, kilowatt/s
abbreviate as kg, kJ, km, kW
LLL
labelled, labelling
led
use this as past tense of the verb ‘lead’
less/fewer
less means smaller in quantity, eg, less drug; fewer means smaller in number, eg, fewer drugs
lifecycle (one word)
lifelong (one word)
leukaemia
licence noun; license verb
a company might apply for a pharmaceutical industry licence; they might be ready to license
their company; or they might have an understanding of pharmaceutical licensing
light year
a measure of distance, not time
like vs such as
‘like’ excludes; ‘such as’ includes: ‘Drugs like aspirin are highly effective’ suggests the writer
has in mind, say, ibuprofen or codeine; the author actually means ‘drugs such as aspirin’.
liquefy
not liquify
lists, in text (the Oxford comma)
the Oxford comma is a comma before the final ‘and’ in lists: straightforward lists (he was
prescribed with ibuprofen, diuretics and bed-rest) do not need one, but sometimes it can help
the reader (the patient had cereal, bacon, eggs, toast and honey, and tea)
MMM
Médecins sans Frontières
international medical aid charity (don’t describe it as French)
Medicaid, Medicare
both US federal health insurance programmes, Medicare primarily covers people over 65 and
has no financial requirements for eligibility; Medicaid is targeted at those on low incomes
member states (do not cap up initial letters). Abbreviate to MS, even when plural (eg, several
MS have adopted...)
more than (not over)
eg, more than 250,000 patients; more than US$1 million
multicentre
no hyphen
multisite [trials]
no hyphen
mutual recognition procedure (MRP)
lower case initial letters
myriad
a large, unspecified number; use as an adjective (there are myriad patients in the trial) or a
noun (there is a myriad of patients in the trial), but not ‘myriads of’
NNN
names, in reporting
• Prominent figures can just be named in articles, with their function at second mention:
‘Thomas Lönngren said yesterday... ‘ (first mention); ‘the Agency’s executive director
added... ‘ (subsequent mentions).
• Where it is thought necessary to explain who someone is, write: ‘Jan Lundberg,
AstraZeneca’s executive vice-president, said’, or: ‘AstraZeneca’s executive vice-president,
discovery research, Jan Lundberg, said’.
• In such cases, the commas around the name indicate there is only one person in the position,
so write ‘the Tory leader, David Cameron, said’ (only one person in the job), but ‘the former
Tory leader Michael Howard said’ (there have been many).
National Institute for Health and Care Excellence (NICE)
‘NICE’ after first mention
the Netherlands (not The Netherlands)
not Holland, which is only part of the country; use Dutch as the adjective
nonclinical (no hyphen) (also preclinical)
notified body (NB)
l/c unless talking about a specific notified body, eg, the UK Notified Body
numbers/numerals
Numbers one to ten are written out, 11 upwards in numerals. Except:
•With abbreviations: 5mg, £4.50
•In titles: 2nd annual meeting of...
•In dates: 1 January 2016
Numbers over a thousand have a comma: 5,000
Millions, billions – use the word, eg: ‘Three million sufferers worldwide...’
OOO
Oceania
a preferable term to Australasia, it is sometimes divided into Near Oceania and Remote
Oceania, and comprises, according to the UN:
Australia/New Zealand
Melanesia (Fiji, New Caledonia, Papua New Guinea, Solomon Islands, Vanuatu)
Micronesia (Guam, Kiribati, Marshall Islands, Federated States of Micronesia, Nauru,
Northern Mariana Islands, Palau)
Polynesia (American Samoa, Cook Islands, French Polynesia, Niue, Pitcairn, Samoa,
Tokelau, Tonga, Tuvalu, Wallis and Futuna Islands)
Often rather than ‘frequently’
one in six, one in 12, etc
should be treated as plural. Compare ‘more than one in six COPD sufferers is 65 or older … ‘
with ‘more than one in six COPD sufferers are 65 or older … ‘ Grammatically, we are talking
not about the noun ‘one’ but the noun phrase ‘one in six’, signifying a group of people, ie, the
phrase represents a proportion. Equally, ‘17%’ or ‘one-sixth’, take plural verbs. ‘Two out of
every seven’ and ‘three out of 10’ take plurals too.
organisations
always in the singular, eg, TOPRA is an organisation for regulatory affairs professionals. It
has members worldwide...
PPP
paradigm, paradigm shift
avoid like the plague! Where appropriate, try using: new strategy, new programme, new
framework, ‘change in strategy’, etc.
past vs last: ‘In the past 15 years...’ not ‘last’
per cent, %
(two words) write in full in text unless used in relation to specification limits (eg, ±5%),
stability conditions (eg, 25°C/65%RH), confidence intervals (eg, 95% confidence interval), or
strength of a product (eg, Product X 0.5% nasal spray); % symbol to be used in tables
physicochemical (no hyphen)
Phase I, II, III, IV (not phase and not 1, 2, 3, 4).
Note: when writing, keep together by using non-break space [CTRL + SHIFT + Spacebar on
PCs; APPLE + Spacebar on Macs]
pipeline
(one word)
planning
not ‘forward planning’ (tautological)
practice
noun; practise verb
preventive
not preventative
primary care trusts (l/c)
principal vs principle
principal = first in importance; principle = standard of conduct
programme for computer software and clinical trial programme (unless part of a US-named
programme, eg, the US FDA’s Medical Device Single Audit Program
publications (see References for fuller details)
Italicise names of all publications.
Single quote marks around article title.
publicly, not publically
QQQ
Quality by Design (QbD)
Quotation marks (always double quotemarks):
• Comma before a quote (or colon if lengthy quote); cap up initial of first word, eg:
Dr Brown said, “In hypertension, the goal is to reduce mortality,” although she agreed there
were other useful endpoints.
• With a full quote, all punctuation is placed inside the quote marks: "In hypertension, the
goal is to reduce mortality."
• For part of a quote, punctuation is placed outside the quote marks: The patient said she was
"in moderate pain" following the operation.
• If most of the sentence is a quote, but perhaps starts with an attribution, put punctuation
inside end quote, eg: The research team’s director said, "In hypertension, the goal is to reduce
mortality."
• For a quote within a quote, use ‘single’ quotation marks.
Quote boxes/pull quotes, layout
Aligned left in a RH column and right in a LH column. Centred in a central column. No full
stop. Italicised. No more than six lines.
Use opening and closing quote marks only if the extract is direct speech in the body text, or if
it is an opinion piece.
RRR
References
Reference numbers in the body text are placed outside the punctuation, and with no space.1
(Please ensure reference numbers are appropriately located within the body text).
Reference listings style as follows:
1. M Bowman, P David. ‘Changes in drug prescribing patterns related to commercial
company funding of continuing medical education’, Journal of Continuing Education
in the Health Professions, 8(2), pp13–20, 1998.
The above reference tells us it is Volume 8, Issue 2, pages 13–20. For page numbers, write out
each number in full eg, pp1126–1129 rather than pp1126–29. Double ‘p’ for page if more
than one page, just one if only one (eg, p7).
If reference includes a URL, it follows the date, should be in brackets and a full stop follows
the closing bracket. The date the website was accessed should be given in its own brackets,
eg, (accessed 1 January 2016).
regulatory affairs (l/c)
regulatory affairs professional (l/c)
Regulatory Affairs Professionals Society (RAPS)
cap up initials
regulatory agency
(l/c, including when talking about a specific agency, eg, the Greek regulatory agency)
Regulatory Rapporteur
not the Regulatory Rapporteur
Always in italics (when fonts allow), ie, Regulatory Rapporteur
‘with regard to’ or ‘with regards to’?
with regard to (no ‘s’) means about or concerning. The other expression meaning the same
thing is ‘as regards’. [‘Regards to’ (with ‘s’) relates to sending your regards (good wishes)
to someone.]
Regulation(s)
cap up initial if a specific Regulation; l/c if referring to regulations in general
SSS
scientific advice (l/c)
side-effect (hyphenate)
Spaces/spacing
• Remove double spaces throughout document (often used following full stops by authors) –
use ‘find and replace’ [CTRL+F].
• Spacing between words – use non-break space for:
Phase I; Article 1; Dr Smith; etc
Speciality vs specialty
Use ‘specialty’ when describing an area of expertise, eg, Dr Johnson’s specialty is
nanotechnology.
Spelling
• Always use English spelling unless giving the name of, eg, a US regulation/law when
original US spelling should be used, eg, FDA Modernization Act.
• Use original Latin spellings (ie, UK spellings) eg, paediatrics; oestrogen; foetus
• UK: -ising, -isation (not izing, -ization), eg, organising, organisation
Subheads/crossheads
Cap up initial of first word only, eg, ‘Pharma fights back tiers’.
SmPC vs SPC (Summary of product characteristics)
Always use SmPC, adopted as the correct terminology by EMA working groups. [Note: SPC
also stands for Supplementary Protection Certificate (EU) and Special Precautions and
Contraindications.]
Split infinitives
Generally acceptable [on the grounds that it adds emphasis where it is important], eg,
to thoroughly check the data
sub-Saharan
TTT
targeted
taskforce
(one word)
that or which?
‘that’ defines, ‘which’ gives extra information (often in a clause enclosed by commas): ‘this is
the house that Jack built’; but ‘this house, which Jack built, is falling down’;
Tip: note that the sentence remains grammatical without ‘that’, but not without ‘which’
titles
• author’s titles (eg, Dr, Mr, Prof) should not be shown in the Author Box, the Contents Page
or the Editorial Team listings
• the titles Professor and Dr should be used every time the person is referred to within an
article
• no full stops after Dr, Prof, etc
• l/c designated job titles, eg, vice-president, president (but President Obama; the Prime
Minister)
treatment-naïve
(hyphenate)
trialling
trillion
a thousand billion (1 followed by 12 noughts), abbreviate like this: $25tn
UUU
uncharted
not unchartered
up to date
no hyphens if, eg, the records are up to date
but: in an up-to-date fashion
upon, use ‘on’
eg, ‘based on’
user testing (l/c)
VVV
very
usually very redundant
veto, vetoes, vetoed, vetoing
vice-chair, vice-chancellor, vice-president
(l/c and hyphenate)
WWW
website
l/c, but cap up ‘on the Web’
website URLs
not underlined. If followed by a sentence, use a full stop at end, if they end a paragraph or
stand alone no full stop.
wellbeing
(one word)
well-known
hyphenate if descriptive, eg, well-known formula; not if the formula is well known
Western (cap up)
as in Western lifestyle, Western diseases; but not geographical areas, eg, western Europe
which or that?
see that or which
while, not whilst
who or whom?
If in doubt, ask yourself how the clause beginning who/whom would read in the form of a
sentence giving he, him, she, her, they or them instead: if the who/whom person turns into
he/she/they, then ‘who’ is right; if it becomes him/her/them, then it should be ‘whom’.
In this example: ‘Johnson was criticised for praising Cameron, whom he admired’ – ‘whom’
is correct because he admired ‘him’.
But in ‘Johnson praised Cameron, who he thought was right’ – ‘who’ is correct, because it is
‘he’ not ‘him’ who is considered right.
XXX
Xerox
TM; use photocopy
x-ray (hyphenate)
[Last updated April 2016]